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

Phase 2

• Conditions: Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
• Interventions: Drug: Rituximab and Bendamustine

• Registration Number: NCT01127841
• Lead Sponsor: Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-08-23
• Primary Completion: 2013-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab and Bendamustine	Rituximab and Bendamustine	-

Primary Outcome Measures

Name	Time	Method
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	Four years	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.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.	Four years

Trial Locations

Locations (18)

Hospital Sant Joan de Reus; 🇪🇸 Reus, Tarragona, Spain

Hospital de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital San Pedro de La Rioja; 🇪🇸 Logroño, La Rioja, Spain

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Costa del Sol; 🇪🇸 Marbella, Malaga, 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 uan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital Son Dureta; 🇪🇸 Mallorca, Spain

Complejo Hospitalario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain

Instituto Oncologico de San Sebastian; 🇪🇸 San Sebastian, Spain

Hospital Universitario de Canarias; 🇪🇸 Tenerife, Spain

Hospital Virgen de la Macarena; 🇪🇸 Sevilla, Spain

Hospital General de Valencia; 🇪🇸 Valencia, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain