Randomized Trial of Chlorambucil Versus Chlorambucil Plus Rituximab Versus Rituximab in MALT Lymphoma
Information source: International Extranodal Lymphoma Study Group (IELSG)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma, Mucosa-Associated Lymphoid Tissue
Intervention: chlorambucil (drug) (Drug); rituximab+chlorambucil (Drug); rituximab (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: International Extranodal Lymphoma Study Group (IELSG) Official(s) and/or principal investigator(s):
Emanuele Zucca, MD, Study Chair, Affiliation: International Extranodal Lymphoma Study Group/Oncology Institute of Southern Switzerland. Bellinzona
Emilio Montserrat, MD, Study Chair, Affiliation: Clinic Hospital Universitari, Hematology. Barcelona
Catherine Thieblemont, MD, Study Chair, Affiliation: Centre Hospitalier Lyon Sud, Hematology. Lyon
Giovanni Martinelli, MD, Study Chair, Affiliation: Hemato-oncology. European Oncology Institute. Milan
Peter Johnson, MD, Study Chair, Affiliation: Oncology Unit. Southampton General Hospital. Southampton
Maurizio Martelli, MD, Study Chair, Affiliation: Hematology. Università La Sapienza. Roma
Overall contact:
Cristina Morinini, Phone: +41 91 8119040, Email: ielsg@ticino.com
Summary
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
Clinical Details
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)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Event-free-survival (EFS) (failure or death from any cause) for all patients
Secondary outcome: Complete and partial remission rates for all patientsResponse 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Cristina Morinini, Phone: +41 91 8119040, Email: ielsg@ticino.com
Oncology Institute of Southern Switzerland - Ospedale San Giovanni, Bellinzona 6500, Switzerland; Recruiting
Cristina Morinini, Phone: +41 91 8119040, Email: ielsg@ticino.com
Additional Information
Click here for more information about this study
Starting date: January 2003
Last updated: July 21, 2009
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