Radiation Therapy Alone for Stage 1 and 2 MALT (Mucosa-Associated Lymphoid Tissue) Lymphoma
Phase: PHASE2
Conditions: Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, Extranodal Marginal Zone Lymphoma
Sponsor: M.D. Anderson Cancer Center

Protocol Page
Radiation Therapy alone for stage 1 and 2 MALT (mucosa-associated lymphoid 
tissue) lymphoma
ID99-384
Core Protocol Information
Short Title 
MALT
Study Chair: 
Bouthaina Dabaja
Additional Contact:
Aileen Mapps
Brittany D. Spinelli
Victoria Cox
Additional Memo Recipients:
Recipients List
OPR Recipients (for OPR use only)
None
Study Staff Recipients
None
Department:
Radiation Oncology
Phone:
713-563-2300
Unit:
97
Study Manager:
Bouthaina Dabaja
Full Title: 
Radiation Therapy alone for stage 1 and 2 MALT (mucosa-
associated lymphoid tissue) lymphoma
Public Description:
n/a
Protocol Type:
Standard Protocol
Protocol Phase:
N/A
Version Status:
Activated -- Closed to new patient entry as of 08/11/2019
Version:
07
Document Status:
Saved as "Final"
Submitted by:
Aileen Mapps--8/7/2019 7:18:06 AM
OPR Action:
Accepted by:  Elaine Kramer -- 8/8/2019 4:45:22 PM
Which Committee will review this protocol?
 The Clinical Research Committee - (CRC)

Protocol Body
1.0 Objectives
1.1To determine the efficacy and toxicity of radiation therapy alone in treating stage 1 and 2 MALT lymphoma for newly 
diagnosed patients and for the patients who failed other treatment modalities. 
2.0 Background
2.1Rationale- MALT lymphoma is a relatively recently described entity which is also known as extranodal marginal zone 
lymphoma (1)(2)(3)(4). It was initially recognized in gastrointestinal tract with the majority arising from the stomach. 
Nowadays, however, about 30 to 40% of the MALT lymphomas are thought to be of non-gastrointestinal origin according 
to the M.D. Anderson Cancer Center lymphoma data base and others (5). Though MALT lymphoma constitute about 7 to 
8%(6) of non-Hodgkin’s lymphoma, prospective clinical trials are scarce and optimal treatments still remain to be defined. 
It is generally considered to be a low grade lymphoma at early state (7)(8) having a very favorable prognosis even after 
localized treatments such as radiation therapy of surgical resection alone (9)(10). Most of the data on the treatments of 
MALT lymphoma come from experiences in gastric MALT lymphoma (11)(12)(13). There have been multiple 
retrospective series suggestive of favorable outcome for these patients. However, the first report on a prospective clinical 
trial in managing Ann Arbor stage 1 and 2 gastric MALT lymphoma with radiation therapy alone was published in 1998 
and has been recently updated (14)(15). Twenty nine patients were treated with a median dose of 30 Gy (range 22.5 to 
43.5) delivered at 1.5 Gy per fraction to the stomach and adjacent lymph nodes. At a median follow-up of 30 months, 94 
% remain disease free. Non-gastric MALT lymphomas (16) (3)(5) have been reported in sites such as bowel (17) lung 
(18), breast (19)(20), skin (21), thyroid gland (22), bladder (23)(24), liver (25) dura (26)(27), esophagus (28) ocular 
adnexa (29)(30) along with other head and neck series limited by a small number of patients treated in a variety of 
different ways including any combination of chemotherapy, radiation therapy and surgery, thus yielding no significant 
insights into the optimal treatment except for the impression that most of them are very localized disease with favorable 
prognosis probably comparable to that of gastric MALT lymphoma (7). Therefore, we propose to prospectively study the 
efficacy and toxicity of radiation treatment for patients with stage 1 and 2 non-gastric MALT lymphoma as well as to verify 
the Memorial Sloan-Kettering Cancer Center data on gastric MALT lymphoma. Of note, a recent publication from the 
Non-Hodgkin’s Lymphoma Classification Project reported an overall failure free survival of about 70% or higher if the 
International Prognostic Index is less than 4 in their retrospective analysis of 72 patients with stage 1 to 4 MALT 
lymphoma (33). Zinzani et al reported 5 year treatment failure rate of 70% for their review of 47 patients with stage 1 and 
2 non-gastric MALT lymphoma(16). Based on the failure free survival curves presented in these studies, we believe it is a 
very reasonable hypothesis to test 75% or higher relapse free survival at 5 years with the majority of the relapses 
occurring within the first 5 years in our group of patients.
The data on the outcomes of the patients who relapse after initial treatment are lacking. The same statistical analysis 
and stopping rule will apply to the patients who are enrolled in this protocol after failure to initial treatment, though this 
may be very stringent criteria for this patient population. 
2.2Preliminary Data- We have recently reported our experience with 39 consecutive patients with MALT lymphoma with 
supradiaphragmatic presentation seen at M.D. Anderson Cancer Center between 1991 and 1997 (34). Ten of them were 
treated with radiation therapy alone. Two of them had stage 2 disease. The median dose was 39.6 Gy at 1.5 to 2.0 Gy 
per fraction. Everyone achieved a clinical complete response. At a median follow-up of 26 months, everyone is alive. Two 
patients experienced recurrence. Both of the recurrences were in the stomach. They were successfully salvaged, 
rendering every patient free of disease at the last follow-up. Of note is six of these 10 patients had primary conjunctiva 
lymphoma making the scope of this experience quite limited. We now propose to extend radiation treatment as the only 
modality to stage 1 and 2 non-gastric MALT lymphomas in general.
3.0 Background Drug Information
Cytotoxic drugs are not a planned part of treatment in this protocol.
4.0 Patient Eligibility
4.1Inclusion Criteria
4.1.1 Patients with newly diagnosed stage 1 and 2 MALT lymphoma are 
eligible for this study. 
4.1.2 Patients with H. pylori positive gastric MALT lymphoma are 
recommended to have 
treatments with antibiotics prior to enrollment to 
this protocol. 
4.1.3
Patients who failed other treatment modalities (e.g. chemotherapy, 
antibiotics therapy etc) are also 
eligible as far as they never had stage 3 or 4 disease during the course of the disease or disease progression to the 
opposite side of the diaphragm. (As the time course of the response to antibiotic therapy can be very variable among 
patients, sometimes requiring more than one year for complete response, failure to antibiotic therapy can be very 
variable among patients, sometimes requiring more than one year for complete response, failure to antibiotic treatment 
will be defined as no response or progression of the disease documented by endoscopy and biopsy.) 
4.1.4 Patients who have had stage 4 diseases due to bilateral parotid gland or 
ocular/ocular adnexal 
involvement or due to multiple sites within Waldeyer’s 
ring will still be eligible.
4.2Exclusion Criteria
4.2.1
Patients who had previous radiation dose to the site of the current primary disease which would lead to 
violation of known radiation tolerance limit of that particular site if treated again.
4.2.2
Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm will be ineligible.

4.2.3
Previous or concurrent malignancy in any form would not be an exclusion criterion. However, patients who 
receive chemotherapy for concurrent malignancy will be excluded from statistical analysis.
4.2.4
Low blood cell counts would not be exclusion criteria as far as the patient is willing to accept supportive 
measures such as transfusions, filgrastim and epoetin.
5.0 Treatment Plan
5.1
Radiation treatment will consist of involved field radiation therapy to primary site and adjacent lymphatics (if 
indicated). Initial fields to encompass the tumor site and the suspected microscopic disease will be taken to 30 to 30.6 Gy. 
Boost to the gross disease to 36 is indicated in some patients when tumor is larger than 5 cm. The only exception would be 
orbital or ocular adnexal lymphoma which may be treated to the final dose of 30 Gy or 30.6 Gy.
a)
CT Planning is required for every patient unless it is technically not feasible. The only exception would be MALT 
lymphoma of the skin which may be treated with electron beams.
b)
Though involved field radiation therapy to stomach only is recommended for stage 1 gastric MALT lymphoma, 
generous fields to encompass the peri-gastric and celiac lymph nodes are recommended if the patient presents with 
recurrent or refractory disease after chemotherapy. Every attempt needs to be made to preserve the function of the left 
kidney by using oblique fields after the initial AP-PA fields are taken to the kidney tolerance. The gastric fields need to be 
simulated and treated with empty stomach for optimum reproducibility. 
6.0 Pretreatment evaluation 
See Appendix A
6.1
A complete history and physical examination including performance status (Appendix B)
6.2
Laboratory studies will include a CBC with differential, platelet count, electrolytes, biochemical survey, TSH (if 
indicated due to the site of the disease), and beta-2 microglobulin. Imaging studies will include PA and lateral chest 
roentgenograms, CT of the neck, chest, abdomen, and pelvis. Esophogogastroduodenoscopy (EGD) needs to be done for 
every patient. If EGD is positive, colonoscopy along with small bowel series will be performed. Unilateral bone marrow 
biopsies will be obtained prior to initiation of therapy.
6.3
Location, type and size of all measurable lesions must be recorded prior to treatment.
7.0 Evaluation During and After Treatment
(See Appendix A)
7.1
Patients will be followed while on treatment with CBC with differential and platelet count only as clinically indicated. 
These will be also obtained at the follow-up visits.
7.2
A biochemical survey will be performed before radiation therapy and at the follow-up visits.
7.3
All initially abnormal imaging studies and endoscopies will be performed 3 months after completion of radiation 
therapy and yearly thereafter. Additional studies will be obtained only if indicated by the interval history and physical 
examination.
7.4
The follow-up visits will be done between 6 weeks to two months, and then every 3-4 months for the first year, every 
4-6 months for the second year, every 6 months for the third & fourth year, and once a year thereafter or as per physician’s 
discretion.
Please note: The post-treatment lab test and follow-up visits can be done less often (than previously stated) depending on the 
clinical judgment of the physicians.
8.0 Criteria for Response and Toxicity
(See Appendices C and E)
8.1
Tumor Measurements
a.
Lesions will be measured in centimeters prior to the course of therapy.
b.
The longest diameter and its perpendicular will be measured for bi-dimensionally measured lesion. Size will be 
reported as the product of the diameters.
c.
Measurements should be made and recorded by the physician.
d.
An estimate of overall objective and subjective response will be made and recorded at each visit.
e.
Endoscopy findings will be mapped out.
8.2Response Definitions

a)
Clinical responses- The guidelines from the ‘Report of an International Workshop to Standardized Response Criteria 
for Non-Hodgkin’s Lymphoma’ will be followed (35). (See Appendix E for Summary of Response Criteria for Non-Hodgkin’s 
Lymphoma)
CR – 1) Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all 
disease-related symptoms if present before therapy, and normalization of the biochemical abnormalities (eg, lactate 
dehydrogenase [LDH] definitely assignable to lymphoma).
2) All lymph nodes and nodal masses must have regressed to normal size (< 1.5 cm in their greatest transverse diameter for 
nodes >1.5 cm before therapy.) Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before 
treatment must have decreased to < 1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum 
of the products of the greatest diameters (SPD).
3) Any macroscopic nodules in any organs detectable on imaging techniques should no longer be present.
4) Flow cytometric, molecular, or cytogenetic studies are not considered part of routine assessment to document persistent 
disease at the present time. 
CR/unconfirmed (Cru) – 1) Those patients who fulfill criteria 1 and 3 above, but with one or more of the following features: 
A residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the 
SPD. Individual nodes that were previously confluent must have regressed by more than 75% in their SPD compared with the 
size of the original mass.
PR – 1) > 50% decrease in SPD of the six largest dominant nodes or nodal masses. These nodes or masses should be 
selected according to the following features: (a) they should be clearly measurable in at least two perpendicular dimension, (b) 
they should be from as disparate regions of the body as possible, and (c) they should be included mediastinal and 
retroperitoneal areas of disease whenever these sites are involved. 
2) No increase in the size of the nodes, liver, or spleen. 
3) No new sites of disease.
Stable disease is defined as less than a PR (see above) but is not progressive disease (see below).
Relapsed disease (CR, Cru) – 1) Appearance of any new lesion or increase by >50% in the size of previously involved sites. 
2) >50% increase in greatest diameter of any previously identified node greater than 1 cm its short axis or in the SPD of more 
than one node.
Progressive disease (PR, nonresponders) – 1 >50% increase from nadir in the SPD of any previously identified abnormal 
node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy.
b. 
Response Assessment
Response is assessed on the basis of clinical radiologic, and pathologic (i.e, bone marrow) criteria. CT scans remain 
the standard for evaluation of nodal disease. Thoracic, abdominal, and pelvic CT scans are recommended even if those 
areas were not initially involved because of the unpredictable pattern of recurrence.
A bone marrow aspirate and biopsy should only be performed to confirm a CR if it is clinically indicated by new 
abnormalities in the peripheral blood counts or blood smear.
c.
Response durations are measured from the time of response (not the beginning of treatment) until there is evidence 
of progressive disease. Progression free survival will be measured from protocol entry.
8.3
Frequency of Response Determination: All lesions must be measured at baseline and then as per section 7.4
8.4
Survival Durations: The survival of patients will be measured from entry into protocol. 
8.5
All toxicities encountered during the study will be evaluated according to the grading system (0-4) in Appendix C. 
Duration and treatment will be recorded. Life-threatening toxicities should be reported immediately to the study chairman 
who in turn must notify the IRB. Should this occur, it will mandate closure of the protocol to patient entry for investigation as 
to the reasons for this and a decision can be taken as to whether the protocol can remain open or should be closed.
9.0 Criteria for Removal from the Study
9.1Progressive disease during radiation therapy which encompasses all known tumors.
9.2The development of unacceptable toxicity defined as unpredictable, irreversible, or Grade 4.
9.3Non-compliance by patient with protocol requirements.
9.4Patient refusal.
10.0 Data and Protocol Management
10.1
Protocol Compliance: The attending physician must see each patient prior to the start of irradiation and at each 
follow-up visit post-treatment. All required interim and pretreatment data should be available and the physician must 
make a designation as to tumor response and toxicity grade.
10.2
Data Entry: Data must be entered into the Protocol Data Management system before therapy can be given. A 
brief explanation for required but missing data should be recorded as a comment.
10.3
Accuracy of Data Collection: The study chairman will be the final arbiter of response or toxicity should be a 
difference of opinion exist.
11.0 Statistical Considerations and Stopping Rules

This is a trial to estimate the relapse-free survival rate (RFS) of patients with gastric and non-gastric MALT lymphoma treated 
with radiation therapy alone. Patient accrual is expected to be 10 – 15 per year for gastric and 5 – 10 per year for non-gastric 
MALT lymphoma at initial presentation. Accrual of less than 5 patients per year for either gastric or non-gastric MALT lymphoma 
is expected for presentation upon failure of other treatment modalities. The patient accrual and outcome analyses will be done 
separately in the following 4 groups: Gastric vs non-gastric MALT at initial presentation vs upon failure to toher treatment(s).
Accrual goals
The accrual goals for the patients at initial presentation are 40 for gastric and 35 for non-gastric MALT lymphoma. Based on the 
expectation that the relapse rate after radiation therapy alone will be 25% and that 70% of the relapsing patients will fail within 5 
years, these numbers will provide a 95% confidence bound of +/- 5.9% for estimating the 2-year RFS. This calculation assumes 
that RFS follows an exponential distribution and we will follow all patients for at least 2 years.
Stopping Rules for patient accrual at initial presentation
Based on the expectation that the relapse rate after radiation therapy alone will be 25% or less, RFS will be evaluated in each of 
the two subgroups of previously untreated patients and accrual stopped in RFS is < 70% after the first 15, 30, or 45 patients 
have been followed for a minimum of 2-years. Assuming that 70% of the relapsing patients will fail within 5 years, computer 
simulations indicate that this stopping rule will terminate patient accrual in both the gastric and non-gastric arms of the trial with 
a probability of 1% if the relapse rate is 25% with a 17% probability if the relapse rate is 50%, and with a probability of 60% if the 
relapse rate is 75%. 
Stopping Rules for patient accrual upon failure to other treatments
When the accrual goals of both gastric and non-gastric MALT lymphoma patients at initial presentation are met, the data for the 
patients who presented upon failure to other treatments will be analyzed. Decision regarding continued accrual of the patients 
will be made on the RFS outcome and patient accrual rate at that time.
As toxicity of 3 or higher is not expected, we do not have a stopping rule based on toxicity. However, any toxicity of 4 or 5 will be 
immediately investigated (see 12.1)
12.0 Reporting Requirements
12.1
Any life-threatening and/or unexpected and serious (Grade 4 or 5) toxicity will be reported immediately to the 
study chair who in turn must notify the Surveillance Committee.
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