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

Sponsor
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas (Other)
Overall Status
Unknown status
CT.gov ID
NCT01127841
Collaborator
(none)
60
Enrollment
18
Locations
1
Arm
77
Duration (Months)
3.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Rituximab and Bendamustine
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Study Start Date :
Jul 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rituximab and Bendamustine

Drug: 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.

Outcome Measures

Primary Outcome Measures

  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 [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

  1. Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response. [Four years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Elche Elche Alicante Spain
2 Hospital San Pedro de La Rioja Logroño La Rioja Spain
3 Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid Spain
4 Hospital Costa del Sol Marbella Malaga Spain
5 Hospital Sant Joan de Reus Reus Tarragona Spain
6 Hospital G. U. de Alicante Alicante Spain
7 Hospital Insular de Gran Canarias Canarias Spain
8 Hospital U. de Gran Canarias Dr. Negrín Canarias Spain
9 Hospital uan Ramón Jiménez Huelva Spain
10 Hospital Son Dureta Mallorca Spain
11 Hospital Universitario Virgen de la Victoria Málaga Spain
12 Complejo Hospitalario de Pontevedra Pontevedra Spain
13 Instituto Oncologico de San Sebastian San Sebastian Spain
14 Hospital Virgen de la Macarena Sevilla Spain
15 Hospital Universitario de Canarias Tenerife Spain
16 Hospital Virgen de la Salud Toledo Spain
17 Hospital General de Valencia Valencia Spain
18 Hospital Universitario La Fe Valencia Spain

Sponsors and Collaborators

  • Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
ClinicalTrials.gov Identifier:
NCT01127841
Other Study ID Numbers:
  • GOTEL/09-01
First Posted:
May 21, 2010
Last Update Posted:
Aug 23, 2013
Last Verified:
Aug 1, 2013
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Rituximab
Bendamustine Hydrochloride

Study Results

No Results Posted as of Aug 23, 2013