Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
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|
|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|
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|
|Elche, Spain||Hospital de Elche||no longer recruiting|
|Logroño, Spain||Hospital San Pedro de La Rioja||no longer recruiting|
|Majadahonda, Spain||Hospital Universitario Puerta de Hierro Majadahonda||no longer recruiting|
|Marbella, Spain||Hospital Costa del Sol||no longer recruiting|
|Reus, Spain||Hospital Sant Joan de Reus||no longer recruiting|
|Alicante, Spain||Hospital G. U. de Alicante||no longer recruiting|
|Canarias, Spain||Hospital Insular de Gran Canarias||no longer recruiting|
|Canarias, Spain||Hospital U. de Gran Canarias Dr. Negrín||no longer recruiting|
|Huelva, Spain||Hospital uan Ramón Jiménez||no longer recruiting|
|Mallorca, Spain||Hospital Son Dureta||no longer recruiting|
|Málaga, Spain||Hospital Universitario Virgen de la Victoria||no longer recruiting|
|Pontevedra, Spain||Complejo Hospitalario de Pontevedra||no longer recruiting|
|San Sebastian, Spain||Instituto Oncologico de San Sebastian||no longer recruiting|
|Sevilla, Spain||Hospital Virgen de la Macarena||no longer recruiting|
|Tenerife, Spain||Hospital Universitario de Canarias||no longer recruiting|
|Toledo, Spain||Hospital Virgen de la Salud||no longer recruiting|
|Valencia, Spain||Hospital Universitario La Fe||no longer recruiting|
|Valencia, Spain||Hospital General de Valencia||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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 endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.
time frame: Four years
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.
|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.|
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