Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
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.
1 other identifier
interventional
60
1 country
18
Brief Summary
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2009
Longer than P75 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 23, 2013
August 1, 2013
4.4 years
March 18, 2010
August 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.
Four years
Study Arms (1)
Rituximab and Bendamustine
EXPERIMENTALInterventions
Rituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Hospital G. U. de Alicante
Alicante, Alicante, Spain
Hospital de Elche
Elche, Alicante, Spain
Hospital Insular de Gran Canarias
Canarias, Canary Islands, Spain
Hospital U. de Gran Canarias Dr. Negrín
Canarias, Canary Islands, Spain
Hospital uan Ramón Jiménez
Huelva, Huelva, 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 Son Dureta
Mallorca, Mallorca, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, Pontevedra, Spain
Instituto Oncologico de San Sebastian
Donostia / San Sebastian, San Sebastian, Spain
Hospital Virgen de la Macarena
Seville, Sevilla, Spain
Hospital Sant Joan de Reus
Reus, Tarragona, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, Spain
Hospital Virgen de la Salud
Toledo, Toledo, Spain
Hospital General de Valencia
Valencia, Valencia, Spain
Hospital Universitario La Fe
Valencia, Valencia, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2010
First Posted
May 21, 2010
Study Start
July 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2015
Last Updated
August 23, 2013
Record last verified: 2013-08