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Completed

NCT Number: NCT00210353

Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma

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

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Key information

Conditions

Lymphoma, Mucosa-Associated Lymphoid Tissue Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

ACZA Campus Stuivenberg, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chlorambucil (drug)

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)

rituximab+chlorambucil

Drug

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

Rituximab

Drug

rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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).

  3. Progression-free-survival (PFS)

    Time frame: 5 years

    Percentage of patients without disease progression after 5 years from trial registration

  4. Overall Survival

    Time frame: 5 years

    Percentage of patients alive after 5 years from trial registration

Sponsors and collaborators

Lead sponsor

International Extranodal Lymphoma Study Group (IELSG)

Other

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2015
Study completion
2016
First posted
Sep 21, 2005
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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