Clinical trial · Interventional
Rituximab and CVP Plus Interferon for Follicular Non Hodgkins Lymphoma (NHL)
Association of Rituximab to Immunochemotherapy With CVP + Interferon in Newly Diagnosed Follicular Lymphoma Patients With Intermediate-high FLIPI Score. Phase II Study.
NCT00842114CI-TRIAL-00021619LNH-Pro-05completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rituximab plus CVP and Interferon chemoimmunotherapy for newly diagnosed Follicular Lymphoma with FLIPI index \>2
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R+CVP+IFN | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- R+CVP+IFN
- description
- 8 cycles of Rituximab plus CVP chemotherapy (Bagley's et al) associated with Interferon for 12 weeks
- interventionNames
- Biological: R+CVP+IFN
Primary outcomes (1)
- measure
- Progression-free survival (PFS) with the CVP + IFNalfa + Rituximab treatment
- timeFrame
- August 2012
Secondary outcomes (1)
- measure
- Overall response (ORR) and complete response (CR) rates. Overall Survival MRD by RT-PCR assay Toxicity
- timeFrame
- August 2012
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.