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

August 22, 2013 updated by: Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain
        • Hospital G. U. de Alicante
      • Canarias, Spain
        • Hospital Insular de Gran Canarias
      • Canarias, Spain
        • Hospital U. de Gran Canarias Dr. Negrín
      • Huelva, Spain
        • Hospital uan Ramón Jiménez
      • Mallorca, Spain
        • Hospital Son Dureta
      • Málaga, Spain
        • Hospital Universitario Virgen de la Victoria
      • Pontevedra, Spain
        • Complejo Hospitalario de Pontevedra
      • San Sebastian, Spain
        • Instituto Oncológico de San Sebastián
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Toledo, Spain
        • Hospital Virgen De La Salud
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Valencia, Spain
        • Hospital General de Valencia
    • Alicante
      • Elche, Alicante, Spain
        • Hospital de Elche
    • La Rioja
      • Logroño, La Rioja, Spain
        • Hospital San Pedro de La Rioja
    • Madrid
      • Majadahonda, Madrid, Spain
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Malaga
      • Marbella, Malaga, Spain
        • Hospital Costa del Sol
    • Tarragona
      • Reus, Tarragona, Spain
        • Hospital Sant Joan de Reus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Four years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

May 20, 2010

First Posted (ESTIMATE)

May 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2013

Last Update Submitted That Met QC Criteria

August 22, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOTEL/09-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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