Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line

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

Official Title
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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.

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

Intervention / Treatment
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* Drug: Rituximab and Bendamustine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. 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. ECOG ≤ 2. Signed written informed consent Exclusion Criteria: Clinical suspicion or documentation of histological transformation. Patients with hypersensitivity to rituximab. Prior autologous or allogeneic transplant. CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis). Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA). HCV infection. HIV infection or other conditions of severe immunosuppression. Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated. Congestive heart failure> NYHA grade 1. Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, ULN) or creatinine clearance <50 ml / h, not related to lymphoma. Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma. Women who are nursing or pregnant. Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma. Severe acute or chronic infection in activity. Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab and Bendamustine<br> | Drug: Rituximab and Bendamustine<br>* Rituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |