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|
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|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.
- 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
- 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.
|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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