Clinical trial · Interventional
Safety and Efficacy of Fludarabine and Cyclophosphamide + Rituximab
Phase II Study of Rituximab in Combination With Fludarabine and Cyclophosphamide for the Treatment of Relapsed Follicular Lymphoma
NCT00393107CI-TRIAL-00000490completedPhase 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)
Purpose of this study was to assess the safety profile and the anti-lymphoma activity of the FC+R combination.
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 |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Drug | Rituximab | ALIAS |
| rituximab,fludarabine, cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Toxicity during the treatment period
- measure
- Efficacy evaluated in terms of complete and partial response 1 month after the end of therapy
Secondary outcomes (1)
- measure
- Efficacy evaluated in terms of molecular response ( bone marrow Bcl2 negativity after treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * histologically documented WHO grade 1-2 ,CD20+,follicular lymphoma * relapsed Follicular lymphoma * stage III or IV disease * Stage II patients are eligible if they present with B symptoms or bulky disease * to have a need for therapy in the opinion of treating clinician * measurable disease * expected survival of 6 months or more * age 18 to 70 years * to have undergone \< 3 lines of chemotherapy * performance status of 0 to 2 Exclusion Criteria: * known HIV infections * Known Hepatitis B or C * CNS lymphoma * previous malignancies, or cardiac, renal, hepatic, or respiratory failure * Pregnant or lactating women and patients of child bearing potential unless using birth control measures
References
Publications (5)
- BACKGROUNDAlas S, Bonavida B. Rituximab inactivates signal transducer and activation of transcription 3 (STAT3) activity in B-non-Hodgkin's lymphoma through inhibition of the interleukin 10 autocrine/paracrine loop and results in down-regulation of Bcl-2 and sensitization to cytotoxic drugs. Cancer Res. 2001 Jul 1;61(13):5137-44. PMID 11431352
- BACKGROUNDAlas S, Emmanouilides C, Bonavida B. Inhibition of interleukin 10 by rituximab results in down-regulation of bcl-2 and sensitization of B-cell non-Hodgkin's lymphoma to apoptosis. Clin Cancer Res. 2001 Mar;7(3):709-23. PMID 11297268
- BACKGROUNDDi Gaetano N, Xiao Y, Erba E, Bassan R, Rambaldi A, Golay J, Introna M. Synergism between fludarabine and rituximab revealed in a follicular lymphoma cell line resistant to the cytotoxic activity of either drug alone. Br J Haematol. 2001 Sep;114(4):800-9. doi: 10.1046/j.1365-2141.2001.03014.x. PMID 11564066
- BACKGROUNDBellosillo B, Villamor N, Colomer D, Pons G, Montserrat E, Gil J. In vitro evaluation of fludarabine in combination with cyclophosphamide and/or mitoxantrone in B-cell chronic lymphocytic leukemia. Blood. 1999 Oct 15;94(8):2836-43. PMID 10515887
- BACKGROUNDSacchi S., Tucci A, Merli F, Orsucci L, Cervetti G, Occhini U, Liberati M, Tarantini G, Callea V, Brugiatelli M, Lauta VM, Baldini L, Luminari S, Federico M. Dipartimento di Oncologia ed Ematologia,. Phase II Study with Fludarabine and Cyclophosphamide Plus Rituximab (FC+R) in Relapsed Follicular Lymphoma Patients. ASH 2002. Blood 99, 2002 Ab n° 530