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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 April 2013 |
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Main ID: |
NCT00210353 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
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Scientific title:
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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) |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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450 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00210353 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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France
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Italy
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Catherine Thieblemont, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Lyon Sud, Hematology. Lyon |
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Name:
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Emilio Montserrat, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinic Hospital Universitari, Hematology. Barcelona |
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Name:
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Giovanni Martinelli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hemato-oncology. European Oncology Institute. Milan |
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Name:
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Maurizio Martelli, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hematology. Università La Sapienza. Roma |
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Name:
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Emanuele Zucca, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona |
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Name:
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Peter Johnson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oncology Unit. Southampton General Hospital. Southampton |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoma, Mucosa-Associated Lymphoid Tissue
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Intervention(s)
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Drug: chlorambucil (drug)
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Drug: rituximab
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Drug: rituximab+chlorambucil
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Primary Outcome(s)
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Event-free-survival (EFS) (failure or death from any cause) for all patients
[Time Frame: 5 years]
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Secondary Outcome(s)
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Acute and long-term toxicity
[Time Frame: 5 years]
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Complete and partial remission rates for all patients
[Time Frame: end of treatment]
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Overall survival for all patients
[Time Frame: 5 years]
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Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients
[Time Frame: 5 years]
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Response duration (time to relapse or progression) for responder patients
[Time Frame: 5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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