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

Browse trials for

• Lymphoma 5,578
• Lymphoma, B-Cell, Marginal Zone 414

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 454 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Lead sponsor

International Extranodal Lymphoma Study Group (IELSG) is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Eligibility criteria

Study arms

• 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)

  Drug: chlorambucil (drug)

• 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

  Drug: rituximab+chlorambucil

• Experimental
  ARM C (Since April 2006)

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

  Drug: rituximab

Interventions

• Drugchlorambucil (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)

• Drugrituximab+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

• Drugrituximab

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

Primary outcomes

1. Event-free-survival (EFS)

   Percentage of patients without events (failure of treatment or Death from any cause) after 5 years from trial registration

   Time frame: 5 years

Secondary outcomes

1. Complete and Partial Remission Rate - Percentage of Patients With Complete and Partial Response at the End of Treatment

   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.

   Time frame: End of treatment (after 24 weeks of therapy)

2. Response Duration (Time to Relapse or Progression) - Percentage of Patients in Continuous Remission at Five Years From Trial Registration

   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).

   Time frame: 5 years

3. Progression-free-survival (PFS)

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

   Time frame: 5 years

4. Overall Survival

   Percentage of patients alive after 5 years from trial registration

   Time frame: 5 years

Baseline characteristics

Publications

• Zucca E, Conconi A, Laszlo D, Lopez-Guillermo A, Bouabdallah R, Coiffier B, Sebban C, Jardin F, Vitolo U, Morschhauser F, Pileri SA, Copie-Bergman C, Campo E, Jack A, Floriani I, Johnson P, Martelli M, Cavalli F, Martinelli G, Thieblemont C. Addition of rituximab to chlorambucil produces superior event-free survival in the treatment of patients with extranodal marginal-zone B-cell lymphoma: 5-year analysis of the IELSG-19 Randomized Study. J Clin Oncol. 2013 Feb 10;31(5):565-72. doi: 10.1200/JCO.2011.40.6272. Epub 2013 Jan 7. PubMed 23295789 ↗

Related links

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