Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
NCT ID: NCT01127841
Last Updated: 2013-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2009-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab and Bendamustine
Rituximab and Bendamustine
Rituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.
Interventions
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Rituximab and Bendamustine
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
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
OTHER
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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GOTEL/09-01
Identifier Type: -
Identifier Source: org_study_id