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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00210353
First received: September 13, 2005
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

Aim of the study is to assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and to 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 Intervention Phase
Lymphoma, Mucosa-Associated Lymphoid Tissue
Drug: chlorambucil (drug)
Drug: rituximab+chlorambucil
Drug: rituximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • Event-free-survival (EFS) (failure or death from any cause) for all patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete and partial remission rates for all patients [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
  • Response duration (time to relapse or progression) for responder patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival for all patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Acute and long-term toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: January 2003
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
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
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
Experimental: ARM C (Since April 2006)
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
Drug: rituximab
rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site
  2. any stage (Ann Arbor I-IV)
  3. either de novo, or relapsed disease following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma)
  4. no evidence of histologic transformation to a high grade lymphoma
  5. measurable or evaluable disease
  6. age > 18
  7. life expectancy of at least 1 year
  8. ECOG performance status 0-2
  9. no prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer
  10. no prior chemotherapy
  11. no prior immunotherapy with any anti-CD20 monoclonal antibody
  12. no prior radiotherapy in the last 6 weeks
  13. 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
  14. 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
  15. no evidence of symptomatic central nervous system (CNS) disease
  16. no impairment of bone marrow function (WBC >3.0x109/L, ANC >1.5x109/L, PLT >100x109/L), unless due to lymphoma involvement
  17. 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
  18. no evidence of active opportunistic infections
  19. no known HIV infection
  20. no active HBV and/or HCV infection
  21. no pregnant or lactating status
  22. appropriate contraceptive method in women of childbearing potential or men
  23. 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
  24. informed consent must be given according to national/local regulations before randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00210353

  Show 75 Study Locations
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
Investigators
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
  More Information

Additional Information:
No publications provided by International Extranodal Lymphoma Study Group (IELSG)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Extranodal Lymphoma Study Group (IELSG), IELSG
ClinicalTrials.gov Identifier: NCT00210353     History of Changes
Other Study ID Numbers: IELSG19
Study First Received: September 13, 2005
Last Updated: September 29, 2014
Health Authority: Switzerland: Swissmedic
Italy: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Chlorambucil
Rituximab
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014