Overview

This trial is active, not recruiting.

Condition follicular non-hodgking´s lymphoma refractory or relapsed after treatment with r-chemotherapy in first line.
Treatment rituximab and bendamustine
Phase phase 2
Sponsor Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
Start date July 2009
End date December 2013
Trial size 60 participants
Trial identifier NCT01127841, GOTEL/09-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rituximab 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.

Primary Outcomes

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
time frame: Four years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas.