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Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab in MALT Lymphoma
This study is currently recruiting participants.
Verified by International Extranodal Lymphoma Study Group (IELSG), September 2005
First Received: September 13, 2005   Last Updated: December 13, 2005   History of Changes
Sponsored by: International Extranodal Lymphoma Study Group (IELSG)
Information provided by: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT00210353
  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


Condition Intervention Phase
Lymphoma, Mucosa-Associated Lymphoid Tissue
Drug: rituximab (drug)
Drug: chlorambucil (drug)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Multicenter Randomized Trial of Chlorambucil Versus Chlorambucil Plus 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

Secondary Outcome Measures:
  • ·Complete and partial remission rates for all patients
  • ·Response duration (time to relapse or progression) for responder patients
  • ·Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients
  • ·Overall survival for all patients
  • ·Acute and long-term toxicity

Estimated Enrollment: 250
Study Start Date: January 2003
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00210353

Contacts
Contact: Cristina Morinini +41 91 8119040 ielsg@ticino.com

Locations
Switzerland
Oncology Institute of Southern Switzerland - Ospedale San Giovanni Recruiting
Bellinzona, Switzerland, 6500
Contact: Cristina Morinini     +41 91 8119040     ielsg@ticino.com    
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

Study ID Numbers: IELSG19
Study First Received: September 13, 2005
Last Updated: December 13, 2005
ClinicalTrials.gov Identifier: NCT00210353     History of Changes
Health Authority: Switzerland: Swissmedic

Study placed in the following topic categories:
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Chlorambucil
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Lymphatic Diseases
B-cell Lymphomas
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Alkylating Agents

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

ClinicalTrials.gov processed this record on July 02, 2009