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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01127841

Enrollment

Registered

2010-05-21

Start date

2009-07-31

Completion date

2015-12-31

Last updated

2013-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.

Brief summary

Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.

Interventions

DRUGRituximab and Bendamustine

Rituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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	Four years	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

Measure	Time frame
Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.	Four years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026