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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

Primary Purpose

Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.

Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Rituximab and Bendamustine
Sponsored by
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Elche
  • Hospital San Pedro de La Rioja
  • Hospital Universitario Puerta de Hierro Majadahonda
  • Hospital Costa del Sol
  • Hospital Sant Joan de Reus
  • Hospital G. U. de Alicante
  • Hospital Insular de Gran Canarias
  • Hospital U. de Gran Canarias Dr. Negrín
  • Hospital uan Ramón Jiménez
  • Hospital Son Dureta
  • Hospital Universitario Virgen de la Victoria
  • Complejo Hospitalario de Pontevedra
  • Instituto Oncologico de San Sebastian
  • Hospital Virgen de la Macarena
  • Hospital Universitario de Canarias
  • Hospital Virgen de la Salud
  • Hospital General de Valencia
  • Hospital Universitario La Fe

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab and Bendamustine

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2010
Last Updated
August 22, 2013
Sponsor
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
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1. Study Identification

Unique Protocol Identification Number
NCT01127841
Brief Title
Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rituximab and Bendamustine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab and Bendamustine
Intervention Description
Rituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Four years
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Hospital de Elche
City
Elche
State/Province
Alicante
Country
Spain
Facility Name
Hospital San Pedro de La Rioja
City
Logroño
State/Province
La Rioja
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Malaga
Country
Spain
Facility Name
Hospital Sant Joan de Reus
City
Reus
State/Province
Tarragona
Country
Spain
Facility Name
Hospital G. U. de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Insular de Gran Canarias
City
Canarias
Country
Spain
Facility Name
Hospital U. de Gran Canarias Dr. Negrín
City
Canarias
Country
Spain
Facility Name
Hospital uan Ramón Jiménez
City
Huelva
Country
Spain
Facility Name
Hospital Son Dureta
City
Mallorca
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra
City
Pontevedra
Country
Spain
Facility Name
Instituto Oncologico de San Sebastian
City
San Sebastian
Country
Spain
Facility Name
Hospital Virgen de la Macarena
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
Country
Spain
Facility Name
Hospital General de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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