sites participating in the study
14.0 references

1. Anon. Global Report: UNAIDS Report on the Global AIDS Epidemic: 2010. 2010. Available at: http://www.unhcr.org/refworld/docid/4cfca9c62.html. Accessed July 31, 2012.  
2. Anon. The Global HIV/AIDS pandemic, 2006. MMWR Morb. Mortal. Wkly. Rep.  
2006;55(31):841–844.  
3. Orem J, Otieno MW, Remick SC. AIDS-associated cancer in developing nations. Curr Opin Oncol. 2004;16(5):468–476.  
4. Wakabi W. Kenya and Uganda grapple with Burkitt lymphoma. Lancet Oncol. 2008;9(4):319. 5. Otieno MW, Remick SC, Whalen C. Adult Burkitt's lymphoma in patients with and without human immunodeficiency virus infection in Kenya. Int. J. Cancer. 2001;92(5):687–691.  
6. Bateganya MH, Stanaway J, Brentlinger PE, et al. Predictors of Survival After a Diagnosis of Non-Hodgkin Lymphoma in a Resource-Limited Setting: A Retrospective Study on the Impact of HIV Infection and Its Treatment. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2011;56(4):312–319.  
7. Krown SE. Cancer in Resource-Limited Settings. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2011;56(4):297–299.  
8. Hesseling P, Broadhead R, Mansvelt E, et al. The 2000 Burkitt lymphoma trial in Malawi.  
Pediatr Blood Cancer. 2005;44(3):245–250.  
9. Hesseling PB, Broadhead R, Molyneux E, et al. Malawi pilot study of Burkitt lymphoma treatment. Med. Pediatr. Oncol. 2003;41(6):532–540.  
10. Mwanda WO, Orem J, Fu P, et al. Dose-Modified Oral Chemotherapy in the Treatment of AIDS-Related Non-Hodgkin's Lymphoma in East Africa. J Clin Oncol. 2009;27(21):3480–3488.  
11. Remick SC, McSharry JJ, Wolf BC, et al. Novel oral combination chemotherapy in the treatment of intermediate-grade and high-grade AIDS-related non-Hodgkin's lymphoma. JCO. 1993;11(9):1691–1702.  
12. Little RF, Pittaluga S, Grant N, et al. Highly effective treatment of acquired immunodeficiency syndrome-related lymphoma with dose-adjusted EPOCH: impact of antiretroviral therapy suspension and tumor biology. Blood. 2003;101(12):4653–4659.  
13. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma.  
J. Clin. Oncol. 2007;25(5):579–586.  
APPENDIX I: **SCHEDULE OF PATIENT ASSESSMENT(S) AND**  
EVALUATION(S)  
| EVALUATION(S)                                                                                                                                                                                                                                                                                                                                                                                      |                        |                        |                        |                      |    |    |    |      |      |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------|------------------------|----------------------|----|----|----|------|------|
| Cycle 1  Day 22  (oral)                                                                                                                                                                                                                                                                                                                                                                            | Cycle 2,  D1 (oral)    | Cycle 2,  D22 (oral)   | Cycle 3,  D1  (oral)   | Cycle 3,  D22 (oral) | Off    |    |    |      |      |
| Treatment  Day 128                                                                                                                                                                                                                                                                                                                                                                                 | Follow-up  until offstudy: 3M,                        |                        |                        |                      |    |    |    |      |      |
| Cycle 2,                                                                                                                                                                                                                                                                                                                                                                                           | 6M, 12M,               |                        |                        |                      |    |    |    |      |      |
| Day 1                                                                                                                                                                                                                                                                                                                                                                                              | 18M, 24M 3             |                        |                        |                      |    |    |    |      |      |
| (CHOP)                                                                                                                                                                                                                                                                                                                                                                                             |                        |                        |                        |                      |    |    |    |      |      |
| Parameter(s)                                                                                                                                                                                                                                                                                                                                                                                       | Baseline               | Cycle 1  Day 1         | Cycle 6,  Day 1 (CHOP) |                      |    |    |    |      |      |
| History &  Physical Exam  including  neurological  exam1                                                                                                                                                                                                                                                                                                                                           | Cycle 3,  Day 1 (CHOP) | Cycle 4,  Day 1 (CHOP) | Cycle 5,  Day 1 (CHOP) |                      |    |    |    |      |      |
| x1                                                                                                                                                                                                                                                                                                                                                                                                 | x1                     | x1                     | x1                     | x1                   | x1 | x1 | x1 | x1   |      |
| Review of interim  medical history,  adverse events,  and concomitant  medications                                                                                                                                                                                                                                                                                                                 | x                      | x                      | x                      | x                    | x  | x  | x  | x    |      |
| Tumor  measurements1,2                                                                                                                                                                                                                                                                                                                                                                             | x1                     | x2                     | x2                     | x2                   | x2 | x2 | x2 | x1,2 | x1,2 |
| CBC, diff. &  plts.4                                                                                                                                                                                                                                                                                                                                                                               | x1,4                   | x4                     | x4                     | x4                   | x4 | x4 | x4 | x4   |      |
| Serum creatinine and total                                                                                                                                                                                                                                                                                                                                                                         | x1,5                   | x5                     | x5                     | x5                   | x5 | x5 | x5 | x5   |      |
| bilirubin5 Electrolytes and  serum                                                                                                                                                                                                                                                                                                                                                                 | x1,6                   | x6                     | x6                     | x6                   | x6 | x6 | x6 | x6   |      |
| chemistries6 Chest x-ray2                                                                                                                                                                                                                                                                                                                                                                          | x2                     | x2                     |                        |                      |    |    |    |      |      |
| Abdomen &  pelvic sonogram                                                                                                                                                                                                                                                                                                                                                                         | x2                     | x2                     |                        |                      |    |    |    |      |      |
| and CT scan2 Bone marrow  aspiration/                                                                                                                                                                                                                                                                                                                                                              | x7                     | x7                     |                        |                      |    |    |    |      |      |
| biopsy7 Lumbar puncture                                                                                                                                                                                                                                                                                                                                                                            | x10                    |                        |                        |                      |    |    |    |      |      |
| CD4 lymphocyte  count, HIV-1                                                                                                                                                                                                                                                                                                                                                                       | x1,9                   | x8                     | x8                     |                      |    |    |    |      |      |
| plasma RNA and  viral load8 Tumor biopsy                                                                                                                                                                                                                                                                                                                                                           | x                      |                        |                        |                      |    |    |    |      |      |
| Urine pregnancy  test                                                                                                                                                                                                                                                                                                                                                                              | x                      | x                      | x                      | x                    | x  | x  | x  |      |      |
| ART Adherence  Assessment                                                                                                                                                                                                                                                                                                                                                                          | x                      | x                      | x                      | x                    | x  | x  |    |      |      |
| Oral Study Drug  Adherence                                                                                                                                                                                                                                                                                                                                                                         | x                      | x                      | x                      | x                    | x  | x  | x  |      |      |
| Assessment 1. Baseline history and physical exam (including neurological exam) must be assessed within 48 hours of initiating therapy and  may count as history and physical exam requirement for Day 1, cycle 1. Subsequent history and physical exams are performed  within the 48 hours prior to Days 1 and 22 of each cycle of chemotherapy, at time of treatment completion (Day 128), and at |                        |                        |                        |                      |    |    |    |      |      |  
panel (sodium, potassium, chloride) with creatinine and serum chemistries including SGOT (AST) or SGPT (ALT), total bilirubin, albumin, uric acid and LDH must be done within 7 days prior to treatment and will suffice as Day 1 pretreatment laboratories.  
2. Baseline assessments of tumor measurements, sonograms, CT scans or X-rays used to document measurable/evaluable disease should be done within 4 weeks prior to initiation of therapy. Imaging studies performed within 2 weeks of treatment initiation are preferable. Lesions on physical examination must be assessed within 48 hours of initiating therapy. Complete restaging including tumor measurements, is performed upon completion of cycle 3 of therapy. Imaging studies which showed evidence of disease at baseline must be repeated at time of re-staging (following cycle 3). Unless the participant has progressed either during treatment or during post treatment follow-up, CT imaging will be repeated at the 6, 12, 18, and 24 month follow-up visits.  
3. Upon treatment completion, patients are followed at time points 3, 6, 12, 18 and 24 months following the treatment discontinuation visit (unless loss to follow up or death). Clinical status will be documented by exam and appropriate imaging modality at the discretion of the treating physician. Participants who have progressed either during study treatment or during post-treatment follow-up will be followed for vital status, adverse events related to study treatment, and for new treatment regimens ONLY, for the duration or remainder of follow-up.  
4. Complete blood count (CBC), differential, and platelet counts are performed within the 48 hours prior to Day 1 and Day 22 of each period of chemotherapy administration, and at treatment completion. It is advisable, but not required, to obtain nadir blood counts on Day 15 and Day 36.  
5. Serum creatinine and total bilirubin are performed within the 48 hours prior to Day 1 and Day 22 of each cycle of chemotherapy
(three 6-week cycles total) and at treatment completion.  
6. Electrolyte panel and serum chemistries are performed within the 48 hours prior to Day 1 and Day 22 of each cycle of chemotherapy (three 6-week cycles total) and at treatment completion: SGOT (AST) or SGPT (ALT), albumin, uric acid and lactate dehydrogenase (LDH).  
7. Bone marrow biopsy - This is performed in all patients at baseline, and must be repeated in patients thought to have clinical complete response if bone marrow was initially involved.  
8. CD4 lymphocyte count and HIV-1 plasma RNA (i.e., viral load determination) - These studies are to be performed at Baseline; and after cycle 3 at completion of treatment (Day 128). Viral load will be measured by HIV plasma RNA PCR. In addition, the antiretroviral regimen must be recorded in the source documents at time of on-study and any changes recorded as well. Furthermore, unless the participant progressed either during treatment or during post treatment follow-up, CD4 lymphocyte count and viral load determination will be performed at one 3 month time point after completing cycle 3 and then at 6 month intervals (i.e. at months 3, 6, 12, 18 and 24) until patient off-study (death or completion of 2 years of follow-up).  
9. The baseline CD4 count must be collected within 30 days prior to enrollment on to the Treatment Segment. 10. A lumbar puncture must be completed within 4 weeks prior to enrollment.  
| APPENDIX II: ECOG PERFORMANCE SCALE   |                                                                                                                                                                                            |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Grade                                 | Descriptions                                                                                                                                                                               |
| 0                                     | Normal activity. Fully active, able to carry out all pre-disease performance  without restriction.                                                                                         |
| 1                                     | Symptoms, but ambulatory. Restricted in physically strenuous activity, but  ambulatory and able to carry out work of a light or sedentary nature (e.g., light  house work or office work). |
| 2                                     | In bed < 50% of the time. Ambulatory and capable of all self care, but unable to  carry out work activities. Up and about for more than 50% of waking hours.                               |
| 3                                     | In bed >50% of the time. Capable of only limited self care. Confined to bed or  chair more than 50% of waking hours.                                                                       |
| 4                                     | 100% bedridden. Completely disabled. Cannot carry on any self care. Totally  confined to bed or chair.                                                                                     |
| 5                                     | Dead                                                                                                                                                                                       |
appendix iii initial pathology review
diagnostic pathology

Initial pathologic diagnosis will be performed by an approved pathologist at the site, and a report confirming a diagnosis of DLBCL will be issued and signed by an approved pathologist prior to a patient entering the trial. This diagnosis will be based on: a) H&E showing a lymphoma with large cell morphology  
b) CD20 or Pax5 immunohistochemistry showing loss of normal architecture, and that the large cells are of B cell origin.  
c) Ki67 to evaluate the percentage of proliferating large cells. Cases with a proliferation rate of
>90% will be excluded from the trial.
These parameters limit the trial to inclusion of patients with the 2008-WHO-defined DLBCL. It excludes Burkitt and Burkitt-like lymphoma and all other subtypes of non-Hodgkin's lymphoma. Additional immunostains performed at the site are allowed but not required, and should be described in the pathology report. Drs. Cesarman, Ely or Tam will be available for consultation on any cases where the site pathologist has questions about the diagnosis or eligibility. In this case, microscopic images of diagnostic areas will be emailed to ecesarm@med.cornell.edu, wtam@med.cornell.edu, and sae2001@med.cornell.edu. A record of cases excluded from the trial will be kept for eventual review. Case review conferences will be held on a regular basis via conference calls.
appendix iii initial pathology review
handling of tissues for external

The appointed pathologist at each site will collect the tissues from each patient entered into the protocol. Either a formalin-fixed, paraffin embedded (FFPE) tissue block, or 15 unstained tissue slides must be made available for centralized pathology review, to be completed upon termination of the trial. A copy of the local pathology report must be submitted with the tissue block or slides for central pathology review. Tissues for external quality assurance pathology review must be batched at each site, and shipped via express mail, every six months to the AMC External Quality Assurance Laboratory at: Sharon Barouk, MA Research Coordinator Laboratory of Hematopathology Department of Pathology and Laboratory Medicine Weill Cornell Medical College/The New York Presbyterian Hospital Starr-702 525 East 68th Street New York, NY 10065 USA Phone: (212) 746-6357 Fax: (212) 746- 8173 Email: shb2016@med.cornell.edu The Weill Cornell Laboratory will destroy residual materials, when a block was submitted upon completion of the pathology review. For sites that request return of the slides and/or blocks, all the materials will be returned by the laboratory to the clinical site. Each sample must be labeled using a Sharpie pen, or other waterproof, permanent marker with the following information: Protocol \#: AMC-068 9 digit Patient \# Date of collection Specimen type: Tissue (tissue block) or Tissue (unstained slide) Specimen purpose: External quality assurance *Note: if unstained slides are collected, only one specimen label should be used for each set and applied to the bag or slide holder in which the slides are kept. The number of slides will need to be entered into the AMC's specimen tracking system, GlobalTraceSM.
appendix iii initial pathology review
specimen accessioning

Upon receipt at Weill Cornell Medical College, each specimen from AMC will receive an Immunopathology Laboratory accession number which will be sequential with the other specimens received. This will avoid delays in processing. Specimens belonging to AMC will be so stated under "Clinical Information", and therefore can be easily identified and tracked. A report will be issued by Dr. Tam or Dr. Ely within a month of receipt, with a diagnosis based on the microscopic review of H&E-stained sections, results of immunohistochemistry, in situ hybridization (EBER) and molecular or cytogenetic analysis (if requested or considered informative for final diagnosis),. All the reports will be sent by FAX to the AMC ODMC as well as to the submitting physician and pathologist, and hard copies will follow.
appendix iii initial pathology review
record of specimens

This study will track specimens via GlobalTraceSM, a component of the AMC AdvantageEDCSM system. The GlobalTraceSM shipment manifest must accompany all specimen shipments.
appendix iii initial pathology review
pathology review

Specimens received from AMC will undergo histopathologic diagnosis and classification, immunostaining and molecular analysis. Pathologic evaluation will be performed by Dr. Tam or Dr. Ely; all interesting, atypical and unusual cases will also be reviewed by Drs. Orazzi and/or Knowles. Specifically, cases will be processed as follows:  
1. H&E 3. Ten immunostains (CD20, CD3, BCL6, BCL2, Mum, CD10, PRDM1, Ki67, p53, LANA) 4. In situ hybridization (EBER) 5. FISH (cMYC, BLC6, BCL2). 6. Pathologist interpretation.
appendix iv amc data and
monitoring the progress of trials

All AMC protocols that collect safety data follow the National Cancer Institute (NCI), Cancer Therapy Evaluation Program (CTEP) Guidelines: Adverse Event Reporting Requirements (http://ctep.cancer.gov/guidelines/index.html). All adverse events that meet the NCI's expedited reporting requirements are reported to the Investigational Drug Branch (IDB) of the NCI via the CTEP Adverse Event Reporting System (CTEP-AERS) web application. All expedited adverse event reports are also required to be submitted to the local Institutional Review Board (IRB) of the reporting institution. If NCI holds the IND or no IND is required for a study, the AMC site reports serious adverse events directly to the AMC Operations and Data Management Center (ODMC) via CTEP-AERS; expedited reporting via AdvantageEDC/Advantage eClinical may be permitted for select commercial agent studies per protocol requirements. In some instances, the AMC sites may report serious adverse events directly to a commercial sponsor holding the IND, who will then report the event to the AMC ODMC. Most AMC protocols require sites to report all serious adverse events via CTEP-AERS and the AMC ODMC to forward a copy of the report to the sponsor. The AMC ODMC also distributes all IND safety reports to all investigators upon receipt, and makes these reports available on the password-protected section of the AMC Operations web site. Unless an AMC protocol specifies an alternate plan for the review and submission of serious adverse events, all serious adverse events received by the AMC ODMC will be reviewed by the AMC Medical Monitor at the AMC ODMC. For protocols for which the IDB does not have an assigned drug monitor to review serious adverse event reports, in the event of disagreement between the reporting physician and the AMC Medical Monitor regarding the attribution of the event to the investigational agent(s) (i.e., determination of whether the relationship is unrelated, unlikely, possible, probable, or definite), the AMC Medical Monitor will provide the final determination of the relationship. The AMC ODMC provides listings of all reported adverse events and serious adverse events to the Protocol Chair and Co-chair(s) for review on a regular basis. The AMC ODMC compiles these events in a tabular format and posts them on the password-protected section of the AMC web site where these reports are updated nightly. The AMC web site is accessible to all AMC investigators, co-investigators, and their staff. Email notification that this information is available on the web site will be sent to all site PIs. It is the responsibility of each site to provide this information to their respective IRBs, if required by their IRB. For blinded studies, the serious adverse events are reviewed and tabulated without treatment assignment. The AMC Medical Monitor will review listings of all reported adverse events on a quarterly basis for safety concerns. Accrual summaries for each AMC trial are updated nightly on the password-protected section of the AMC web site. The progress of each AMC trial is reviewed regularly by the Protocol Chair and also by the appropriate disease-oriented Working Group during scheduled conference calls. For pilot or phase I dose escalation trials, dose escalation (or dose de-escalation) is based on the rules in the protocol and the Protocol Chair, AMC Medical Monitor, and Group Statistician determine whether these criteria have been met. For phase II trials, stopping the trial for toxicity or efficacy, or suspending enrollment pending observation of responses in a multi-stage phase II trial, is based on meeting criteria stated in the protocol, and the Protocol Chair, AMC Medical Monitor, and Group Statistician determine whether these criteria have been met. For phase III trials and other select studies requiring additional oversight, the AMC has formed an independent Data and Safety Monitoring Board (DSMB). Voting members of the DSMB are physicians, a statistician, and a patient advocate. All voting members are from outside the AMC. Nonvoting members are the AMC Group Statistician, the protocol statistician, an AMC Operations Center staff member, two representatives (normally a clinician or statistician) from the Office of HIV AIDS Malignancy (OHAM) or from the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, of the National Cancer Institute (NCI). The DSMB reviews AMC phase III studies in accordance with the National Cancer Institute's Policy for Data and Safety Monitoring. Confidential reports of all phase III trials are prepared by the AMC Group Statistician with support from the AMC ODMC. A written report containing the current status of each trial monitored, and when appropriate, any toxicity and outcome data, are sent to DSMB
members by the AMC ODMC within the timelines specified by the DSMB Charter. This report addresses specific toxicity concerns as well as concerns about the conduct of the trial. The report may contain recommendations for consideration by the DSMB concerning whether to close the trial, report the results, or continue accrual or follow-up. The results of each DSMB meeting are summarized in a formal report sent by the DSMB Chair to the Group Chair and AMC ODMC. The DSMB report contains recommendations on whether to close each study reviewed, whether to report the results, and whether to continue accrual or followup. A primary recommendation (e.g., continue with no change; recommended or required modification; stop) must be included in the document. The Group Chair is then responsible for notifying the Protocol Chair and relevant Disease-oriented Working Group Chair before the recommendations of the DSMB are carried out. In the unlikely event that the Protocol Chair does not concur with the DSMB, then the NCI Division Director or designee must be informed of the reason for the disagreement. The Study Chair, relevant Disease-oriented Working Group Chair, Group Chair, DSMB Chair, and NCI Division Director or designee will be responsible for reaching a mutually acceptable decision about the study. CTEP approval of a formal amendment will be required prior to any implementation of a change to the study. Following a DSMB meeting, a summary of the serious adverse events reported to the DSMB is posted to the AMC web site. It is each site's responsibility for conveying this information to its IRB.
appendix iv amc data and
plans for assuring compliance with

For trials monitored by the NCI's Clinical Data Update System (CDUS), adverse event information is transmitted electronically to NCI on a quarterly basis. For trials monitored by NCI's Clinical Trials Monitoring Service (CTMS), adverse event information is transmitted electronically to NCI every two weeks. The Protocol Chair, AMC Group Chair, and the AMC ODMC share responsibility in assuring that participating investigators comply with the protocol requirements for adverse event reporting. All AMC investigators certify compliance with NCI and FDA requirements for adverse event reporting by signing the AMC Adherence Statement for site membership, the protocol signature page for each protocol active at the site, and Form FDA-1572 for CTEP investigator registration and IND studies sponsored by AMC investigators. Investigators are responsible for identifying and reporting all adverse events to the AMC ODMC, CTEP-AERS, and/or sponsors according to the protocol requirements, and assuring compliance with reporting to the local IRB. Protocol compliance with adverse event reporting requirements is assessed by the AMC ODMC during routine site audits by reviewing the site's source documentation. The data entry system used for AMC studies, AdvantageEDC/Advantage eClinical (a web-based data entry and enrollment system), is programmed to notify the site investigator, protocol chair, AMC Medical Monitor, and AMC ODMC via email in the event that a site reports an adverse event that meets expedited reporting criteria to NCI and/or FDA. If the site does not follow with an expedited report, the AMC ODMC contacts sites to request compliance with reporting requirements. Additionally, the protocol chair, AMC ODMC, and the AMC Medical Monitor review reported adverse events on a routine basis to identify adverse events reported by sites that require expedited reporting. The Protocol Chair, AMC Group Chair, and IND sponsors have general oversight for assuring that routine and expedited adverse reporting requirements are met by the responsible parties.
appendix iv amc data and
plans for assuring that any

In the event that termination of the trial or major modification to the protocol is under consideration, the Protocol Chair will convene the AMC Data Coordinator and Disease-oriented Working Group Chair by conference call to discuss the options. For phase I and II trials, the Protocol Chair also has the option of asking the DSMB to review the study. The AMC ODMC will inform the CTEP Protocol Information Office (PIO) when studies are temporarily or permanently closed. The Cancer Treatment and Evaluation Program (CTEP) of the National Cancer Institute (NCI) must approve all protocol amendments prior to distributing to the AMC sites.
appendix iv amc data and
plans for assuring data accuracy

All study data for AMC clinical trials are entered directly by AMC clinical site staff into AdvantageEDC/Advantage eClinical. During data entry, the system performs validation checks on many fields and performs consistency checks between select fields. Range checks are placed on each field to eliminate entry of out-of-range values. Edit check programs are run on the database on a set schedule to identify and resolve inconsistencies between forms or data collected at different points in time. AMC ODMC staff routinely interacts with site staff to resolve any data problems. In accordance with NCI guidelines, the AMC ODMC conducts audits at the AMC sites to evaluate compliance with regulatory issues, and to review data for specific cases by checking source documents. These reports are sent to the site Principal Investigator and to the NCI. In the event that major violations are identified, sites are asked to provide a written corrective and preventive action plan to correct deficiencies. If needed, a repeat site audit is conducted. In the event that a site does not correct deficiencies in a pre-determined time frame, the AMC Executive Committee has the option of taking action against the site. Possible actions include, but are not limited to, suspending enrollment of new patients to AMC trials until deficiencies are corrected; recommending a decrease in funding to the site; and requiring specific training for site investigators or staff members.
appendix v amc-068 study drug
plans for assuring data accuracy

Site Staff: Please complete the study drug instruction worksheet below. Circle the picture of the agent the participant should take.
appendix v amc-068 study drug
please take your study drugs

Drug Name: _____________________________ Please take __________ pills for __________ days. You should take this medication on (day and date): _____________________________ _____________________________ _____________________________ _____________________________ _____________________________ Drug Name: _____________________________ Please take __________ pills for __________ days. You should take this medication on (day and date): _____________________________ _____________________________ _____________________________ _____________________________ _____________________________
amc-068 oral regimen drug diary
please take your study drugs

The following fields are to be completed by the site staff before the diary is given to the study participant.  
| Participant Number: ________________________________ Treatment Cycle: ________________________________ Date Agent Dispensed: ____________________________ Number of Lomustine pills/day: ___________________ Number of Etoposide pills/day: ____________________   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
Participants: The study investigator or nurse will tell you how many pills to take. Please write the date you took each drug and how many pills you took.  
| Day 1                              | Day 2              | Day 3         |           |           |
|------------------------------------|--------------------|---------------|-----------|-----------|
| Date                               |                    |               |           |           |
| Medication (name)                  | Medication (photo) | Number of     | Number of | Number of |
| Tablets Taken                      | Tablets Taken      | Tablets Taken |           |           |
| Lomustine (CCNU) Etoposide (VP-16) |                    |               |           |           |  
The following fields are to be completed by the site *staff before the diary is given to the study participant*  
| Participant Number: _________________________________ Treatment Cycle: _________________________________ Date Agent Dispensed: ____________________________ Number of Cyclophosphamide pills/day: ___________________ Number of Procarbazine pills/day: ____________________   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
Participants: The study investigator or nurse will tell you have many pills to take. Please write the date you took each drug and how many pills you took.  
| Day 22                                      | Day 23        | Day 24        | Day 25        | Day 26        |               |           |
|---------------------------------------------|---------------|---------------|---------------|---------------|---------------|-----------|
| Date                                        |               |               |               |               |               |           |
| Medication (name)                           | Medication    | Number of     | Number of     | Number of     | Number of     | Number of |
| (photo)                                     | Tablets Taken | Tablets Taken | Tablets Taken | Tablets Taken | Tablets Taken |           |
| Cyclophosphamide (CTX) Procarbazine (Proc.) |               |               |               |               |               |           |
appendix vi amc-068 study drug
please take your study drugs

Site Staff: *Please complete the study drug instruction worksheet below. Circle the picture of the* agent the participant should take. Please take your study drugs as follows: Drug Name: _____________________________ Please take __________ pills for __________ days. You should take this medication on (day and date): _____________________________ _____________________________ _____________________________ _____________________________ _____________________________
amc-068 chop regimen drug diary
please take your study drugs

The following fields are to be completed by the site staff before the diary is given to the study participant Participant Number: _________________________________ Treatment Cycle: _________________________________ Date Agent Dispensed: ____________________________ Number of Prednisone pills/day: ___________________
Participants: The study investigator or nurse will tell you have many pills to take. Please write the date you took each drug and how many pills you took.  
| Day 1             | Day 2         | Day 3         | Day 4         | Day 5         |               |           |
|-------------------|---------------|---------------|---------------|---------------|---------------|-----------|
| Date              |               |               |               |               |               |           |
| Medication (name) | Medication    | Number of     | Number of     | Number of     | Number of     | Number of |
| (photo)           | Tablets Taken | Tablets Taken | Tablets Taken | Tablets Taken | Tablets Taken |           |
| Prednisone        |               |               |               |               |               |           |