Status:
COMPLETED
Rituximab and CVP Plus Interferon for Follicular Non Hodgkins Lymphoma (NHL)
Lead Sponsor:
Fundación Leucemia y Linfoma, Spain
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Rituximab plus CVP and Interferon chemoimmunotherapy for newly diagnosed Follicular Lymphoma with FLIPI index \>2
Detailed Description
This study is a multicentric trial evaluating the efficacy of the CVP chemotherapy + Interferon (IFN) + Rituximab induction regimen in patients aged 18 to 75 years with newly diagnosed follicular NHL....
Eligibility Criteria
Inclusion
- Age 18 years-75 years
- Pathologically confirmed low grade, Follicular B cell lymphoma (WHO Classification Follicular grades 1 and 2) , Marginal zone lymphoma or Lymphocytic lymphoma (excluding CLL and MCL)
- FLIPI score ≥ 2
- Chemotherapy-naïve patients. Previous radiation therapy is allowed, but should have been limited.
- Adequate hepatic (bilirubin or ALT/AST \< 2,5 times UNL) and renal function, except for those directly disease-related
- Performance status grade 0 to 3
- Frozen biopsy material obtained at relapse or disease progression should be available for central pathology review and molecular biology studies
- Patient information and written informed consent
Exclusion
- Previous evolutive malignancy within 5 years of study entry
- Prior chemotherapy treatment
- Clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months of study entry
- Known positivity for HIV, VHB or VHC
- Pregnant or lactating women. Women of childbearing potential, and all men, unwilling to take appropriate contraceptive measures during and for at least 12 months after cessation of therapy
- Any uncontrolled serious non malignant condition or infection which would likely compromise the study objectives
- Non controlled thyroid disfunction
- Severe Autoimmune disease
- Patients with history of severe neuropsychiatric disease
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00842114
Start Date
February 1 2006
End Date
March 1 2016
Last Update
April 4 2016
Active Locations (1)
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1
Hospital Universitario de La Princesa
Madrid, Madrid, Spain, 28006