Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma - Full Text View

Sponsor:	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.

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 III

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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab Chlorambucil

U.S. FDA Resources

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:

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

Contacts and Locations

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:

Click here for more information about this study This link exits the ClinicalTrials.gov site

No publications provided

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:	November 29, 2011
Health Authority:	Switzerland: Swissmedic; Italy: Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:

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
Chlorambucil

Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012