Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
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| ClinicalTrials.gov Identifier: NCT00210353 |
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Recruitment Status :
Completed
First Posted : September 21, 2005
Results First Posted : June 6, 2019
Last Update Posted : June 6, 2019
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Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.
In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Mucosa-Associated Lymphoid Tissue | Drug: chlorambucil (drug) Drug: rituximab+chlorambucil Drug: rituximab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 454 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma) |
| Study Start Date : | January 2003 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | February 17, 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: ARM A
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles)
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Drug: chlorambucil (drug)
chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) |
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Experimental: ARM B
rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle
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Drug: rituximab+chlorambucil
rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle |
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Experimental: ARM C (Since April 2006)
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
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Drug: rituximab
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140 |
- Event-free-survival (EFS) [ Time Frame: 5 years ]Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration
- Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment [ Time Frame: End of treatment (after 24 weeks of therapy) ]
Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma.
Complete response. Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters).
Partial response. Decrease by at least 50% in SPD of the six largest measurable lesions. It is not necessary for all lesions to have regressed to qualify for partial response, but no lesion should have progressed and no new lesion should appear.
For primary gastric sites, response was based on GELA histologic grading system.
- Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration [ Time Frame: 5 years ]
Response criteria were defined according to the NCI standardized response criteria for non-Hodgkin's lymphoma.
Complete response (CR). Disappearance of all detectable clinical and radiographic evidence of disease, disappearance of all disease-related symptoms, if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Regression of all lymph nodes and nodal masses to normal (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before therapy and to ≤ 1 cm for nodes that were 1.1-1.5 cm. Regression by more than 75% in the sum of the products of the greatest diameters).
- Progression-free-survival (PFS) [ Time Frame: 5 years ]Percentage of patients without disease progression after 5 years from trial registration
- Overall Survival [ Time Frame: 5 years ]Percentage of patients alive after 5 years from trial registration
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
- any stage (Ann Arbor I-IV)
- either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
- no evidence of histologic transformation to a high grade lymphoma
- measurable or evaluable disease
- age > 18
- life expectancy of at least 1 year
- ECOG performance status 0-2
- no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
- no prior chemotherapy
- no prior immunotherapy with any anti-CD20 monoclonal antibody
- no prior radiotherapy in the last 6 weeks
- no corticosteroids during the last 28 days, unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms
- no evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry
- no evidence of symptomatic central nervous system (CNS) disease
- no impairment of bone marrow function (WBC >3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement
- no major impairment of renal function (serum creatinine <1,5x upper normal) or liver function (ASAT/ALAT <2,5 upper normal, total bilirubin <2,5x upper normal), unless due to lymphoma involvement
- no evidence of active opportunistic infections
- no known HIV infection
- no active HBV and/or HCV infection
- no pregnant or lactating status
- appropriate contraceptive method in women of childbearing potential or men
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- informed consent must be given according to national/local regulations before randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210353
Show 75 study locations
| Study Chair: | Emanuele Zucca, MD | International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona | |
| Study Chair: | Emilio Montserrat, MD | Clinic Hospital Universitari, Hematology. Barcelona | |
| Study Chair: | Catherine Thieblemont, MD | Centre Hospitalier Lyon Sud, Hematology. Lyon | |
| Study Chair: | Giovanni Martinelli, MD | Hemato-oncology. European Oncology Institute. Milan | |
| Study Chair: | Peter Johnson, MD | Oncology Unit. Southampton General Hospital. Southampton | |
| Study Chair: | Maurizio Martelli, MD | Hematology. Università La Sapienza. Roma |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | International Extranodal Lymphoma Study Group (IELSG) |
| ClinicalTrials.gov Identifier: | NCT00210353 |
| Other Study ID Numbers: |
IELSG19 |
| First Posted: | September 21, 2005 Key Record Dates |
| Results First Posted: | June 6, 2019 |
| Last Update Posted: | June 6, 2019 |
| Last Verified: | October 2018 |
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Lymphoma Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin |
Rituximab Chlorambucil Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |