Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line. Clinical Trial
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.
| Verified date | August 2013 |
| Source | Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.
| Status | Unknown status |
| Enrollment | 60 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital G. U. de Alicante | Alicante | |
| Spain | Hospital Insular de Gran Canarias | Canarias | |
| Spain | Hospital U. de Gran Canarias Dr. Negrín | Canarias | |
| Spain | Hospital de Elche | Elche | Alicante |
| Spain | Hospital uan Ramón Jiménez | Huelva | |
| Spain | Hospital San Pedro de La Rioja | Logroño | La Rioja |
| Spain | Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Universitario Virgen de la Victoria | Málaga | |
| Spain | Hospital Son Dureta | Mallorca | |
| Spain | Hospital Costa del Sol | Marbella | Malaga |
| Spain | Complejo Hospitalario de Pontevedra | Pontevedra | |
| Spain | Hospital Sant Joan de Reus | Reus | Tarragona |
| Spain | Instituto Oncologico de San Sebastian | San Sebastian | |
| Spain | Hospital Virgen de la Macarena | Sevilla | |
| Spain | Hospital Universitario de Canarias | Tenerife | |
| Spain | Hospital Virgen de la Salud | Toledo | |
| Spain | Hospital General de Valencia | Valencia | |
| Spain | Hospital Universitario La Fe | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response. | Four years |