A Phase Ib/II Study of Escalating Doses of Revlimid in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

The Lymphoma Academic Research Organisation24 sites in 1 country80 target enrollmentDecember 2010

ConditionsFollicular Lymphoma

InterventionsLenalidomide and R-CHOP

DrugsLenalidomide and R-CHOP

Overview

Phase: Phase 2
Intervention: Lenalidomide and R-CHOP
Conditions: Follicular Lymphoma
Sponsor: The Lymphoma Academic Research Organisation
Enrollment: 80
Locations: 24
Primary Endpoint: Complete Response Rate (CR+CRu)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

November 2015

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Lymphoma Academic Research Organisation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with follicular lymphoma, (WHO) grade 1, 2 or 3a with at least one of the following signs requiring initiation of treatment:
•Bulky disease according to the GELF criteria: nodal or extra-nodal mass \>7cm in its greater diameter
•B symptoms
•Elevated serum (LDH) or beta 2-microglobulin
•Involvement of at least 3 nodal sites (each \>3cm)
•Symptomatic spleen enlargement
•Compressive syndrome
•Pleural or peritoneal effusion
•Aged from 18 to 70 years
•WHO performance status 0, 1 or 2

Exclusion Criteria

•Previous treatment with immunotherapy or chemotherapy:
•Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion
•Rituximab alone during less than three months, if stopped more than one year before inclusion
•Previous radiotherapy except if localized to one lymph node area
•Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative
•Central nervous system or meningeal involvement
•Contraindication to any drug contained in the chemotherapy regimen
•(HIV) disease, active hepatitis B or C
•Any serious active disease or co-morbid medical condition (according to investigator's decision)
•Any of the following laboratory abnormalities.

Arms & Interventions

Lenalidomide dose 25 mg

Intervention: Lenalidomide and R-CHOP

Outcomes

Primary Outcomes

Complete Response Rate (CR+CRu)

Time Frame: at the end of complete treatment, average of 24 weeks

Secondary Outcomes

Overall survival(from the date of inclusion, average of 6 years)
Duration of response(from the date of first documentation of a response, average of 24 weeks)