MedTrace Logo

Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Relapsed/Refractory Follicular and Aggressive B-cell Lymphoma

NCT01582776 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2023-03-17

No results posted yet for this study

Summary

This study is to determine first the appropriate dose of lenalidomide to administer in combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma patients.

In a second step, this study aims to determine the efficacy of this combination in 3 separate populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and previously untreated follicular lymphoma (cohorts 3 and 4).

Conditions

  • Follicular Lymphoma Patients (Phase IB)
  • Follicular and Agressive (DLBCL&MCL) B-cell Lymphoma Patients (Phase II)

Interventions

DRUG

Lenalidomide and GA101

1000mg of GA101 on D8, D15 and D22of cycle 1 and on D1 of cycles 2 to 6. Oral lenalidomide once daily at 10/15/20/25mg (phase I part) or at recommended dose (phase II part) on days 1 to 21 of a 28-day cycle for the first cycle and on days 2 to 22 of a 28-day cycle for cycles 2 to 6.

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Franck MORSCHHAUSER, Professor · Lymphoma Study Association

  • Roch HOUOT, Professor · Lymphoma Study Association

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-03
Primary Completion
2018-07-11
Completion
2022-05-20

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582776 on ClinicalTrials.gov