Clinical trial NCT00504504: Rituximab and ABVD for Hodgkin's Patients
Official title: A Phase II Study of Rituximab + ABVD for Patients With Hodgkin's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Hodgkin's Disease
Lymphoma
Rituximab
Rituxan
Adriamycin
Doxorubicin
Rubex
Bleomycin
Bleomycin sulfate
Blenoxane
BLM
Dacarbazine
DTIC
DTIC-Dome
Vincristine
Vinblastine
Vinblastine Sulfate
ABVD
ABVD Chemotherapy Treatment
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-07-20
Enrollment: 85
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD combination chemotherapy.

ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.

Detailed description: Before treatment starts, patients will have a physical exam. Bone marrow samples will be taken. Blood samples (4 to 8 tablespoons) will be taken before and during the study. A chest x-ray, CT scans of the abdomen and pelvis, and a gallium scan will be done if necessary.

Patients in this study will receive rituximab by vein over 3 to 8 hours weekly for 6 weeks in a row. ABVD will be injected over 3 hours every other week for a total of 12 treatments. On the cycles where both rituximab and ABVD are given, rituximab will be given on day 1, and ABVD will be given on day 2. Response to therapy will be determined after 3 months and at the end of therapy (6 months). At the end, patients may receive radiation therapy to areas of large masses. All treatments can be given in an outpatient setting.

Scans and x-rays will be repeated if needed after completion of therapy and every 3 months from then on. If tumors do not shrink after 3 months of therapy, patients will be offered a different treatment.

This is an investigational study. Although ABVD is considered the standard treatment for patients with Hodgkin's disease, the combination of ABVD with rituximab is considered investigational. All drugs involved in this study are commercially available and are approved by the FDA. Up to 85 patients will take part in this study. All will be enrolled at M. D. Anderson. This protocol is partially funded by a research grant from Genentech.

Eligibility criteria: Inclusion Criteria:

1. Hodgkin's disease patients who relapse after radiation therapy alone and previously untreated patients with stage II bulky, III and IV who are eligible for ABVD.
2. Must have histologically proven diagnosis of Hodgkin's disease (Nodular sclerosis or mixed cellularity).
3. Must have bidimensionally measurable disease.
4. Must sign a consent form.
5. Must be older than 16 years of age.
6. Must have adequate bone marrow reserve (ANC \> 1,000/microL, Platelet \> 100,000/microL
7. Left Ventricular Ejection Fraction (LVEF) \>/= 50% by multigated acquisition (MUGA) scan or echocardiogram.
8. Serum creatinine \< 2 mg/dl, serum bilirubin \< 2 mg/dl

Exclusion Criteria:

1. HIV positive.
2. Pregnant women and women of child bearing age who are not practicing adequate contraception.
3. Prior chemotherapy.
4. Severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.

Primary outcomes:
measure: 5-year Failure-free Survival Rate for Participants With Hodgkin's Disease Given Rituximab With ABVD
timeFrame: Baseline to 5 Years or until disease progression
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD . Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anas Younes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Younes A, Oki Y, McLaughlin P, Copeland AR, Goy A, Pro B, Feng L, Yuan Y, Chuang HH, Macapinlac HA, Hagemeister F, Romaguera J, Samaniego F, Fanale MA, Dabaja BS, Rodriguez MA, Dang N, Kwak LW, Neelapu SS, Fayad LE. Phase 2 study of rituximab plus ABVD in patients with newly diagnosed classical Hodgkin lymphoma. Blood. 2012 May 3;119(18):4123-8. doi: 10.1182/blood-2012-01-405456. Epub 2012 Feb 27.