Clinical trial · Interventional
Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
NCT01127841CI-TRIAL-00011833unknownPhase 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)
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.
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 Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line. | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab and Bendamustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab and Bendamustine
- interventionNames
- Drug: Rituximab and Bendamustine
Primary outcomes (1)
- measure
- the primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
- timeFrame
- Four years
- description
- Evaluation of response to induction treatment at 6 months after inclusion of the patient. Evaluation of response to maintenance treatment at 2 years after finishing the induction treatment.
Secondary outcomes (1)
- measure
- Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.
- timeFrame
- Four years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. 3. Follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (R-CHOP, R-CVP, R-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment. 4. ECOG ≤ 2. 5. Signed written informed consent Exclusion Criteria: 1. Clinical suspicion or documentation of histological transformation. 2. Patients with hypersensitivity to rituximab. 3. Prior autologous or allogeneic transplant. 4. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis). 5. Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA). 6. HCV infection. HIV infection or other conditions of severe immunosuppression. 7. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated. 8. Congestive heart failure\> NYHA grade 1. 9. Impaired renal function (creatinine\> 1.5 x Upper Limit of Normal, ULN) or creatinine clearance \<50 ml / h, not related to lymphoma. 10. Impaired liver function (bilirubin, AST / ALT or GGT\> 2 x ULN) were not related to lymphoma. 11. Women who are nursing or pregnant. 12. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma. 13. Severe acute or chronic infection in activity. 14. Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.