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Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Relapsed/Refractory Follicular and Aggressive B-cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

A Phase Ib/II Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Follicular and Relapsed/Refractory Aggressive (DLBCL and MCL) B-cell Lymphoma

NCT01582776•The Lymphoma Academic Research Organisation

View on ClinicalTrials.gov

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).

Detailed Description

This study is an open label, multicenter study with two phases: The Phase IB part of the study is a dose escalation study of lenalidomide (Revlimid) administered orally during on 3 weeks of every 28-day cycle, in combination with fixed doses of obinutuzumab (GA101) in relapsed/refractory follicular lymphoma patients. The Phase II part of the study is an efficacy study of the association of the recommended dose of lenalidomide associated with GA101 in 2 separate populations of patients: 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). First, all patients will receive a combination of obinutuzumab and lenalidomide for a total of 6 cycles. Patients who achieve at least a partial response after 6 cycles will receive a maintenance treatment with obinutuzumab for 2 years and Lenalidomide for 1 year as tolerated, or until disease progression.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Phase IB only: Histologically documented CD20-positive follicular lymphoma (WHO grade 1, 2, or 3a) patients
•Phase II: Patients with either histologically documented CD20-positive Diffuse large-cell lymphoma or Mantle cell lymphoma (cohort 1) or follicular lymphoma, WHO grade 1, 2 or 3a (cohort 2-3-4)
•Phase IB and II:
•Relapsed/refractory NHL after ≥1 prior R-containing regimen with no curative option (cohort 2 only)
•Aged 18 years or more
•ECOG performance status 0, 1 or 2
•At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter \> 1.5 cm and a short axis ≥ 10mm
•Signed inform consent
•Life expectancy ≥ 3 months.
•All subjects must be able to understand and fulfill the lenalidomide Pregnancy Prevention Plan requirements (see in appendix)
+1 more criteria

Exclusion Criteria

•Previous treatment with obinutuzumab or lenalidomide
•Known CD20 negative status at relapse/progression. Biopsy at relapse/progression is recommended but not mandatory
•Central nervous system or meningeal involvement by lymphoma
•Contraindication to any drug contained in the study treatment regimen
•Known HIV or HTLV-1 infection, positive serology to HB surface antigen \[HBsAg\] or total HB core antibody \[anti-HB-c\]) and Hepatitis C (Hepatitis C virus \[HCV\] antibody)
•Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
•Any of the following laboratory abnormalities unless secondary to underlying lymphoma:
•* Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L).
•* Platelet count \< 100,000/mm3 (100 x 109/L) unless due to lymphoma for phase II part.
•* Serum SGOT/AST or SGPT/ALT 3.0 x upper limit of normal (ULN) unless disease involvement.
+11 more criteria

Locations (25)

ZNA Stuivenberg

Antwerp, Belgium

A.Z. Sint Jan AV

Bruges, Belgium

institut Jules Bordet

Brussels, Belgium

Université Catholique de Louvain Saint Luc

Brussels, Belgium

AZ Groeninge - Campus Maria's Voorzienigheid

Kortrijk, Belgium

CHU de Liège

Liège, Belgium

Université Catholique de Louvain Mont Godinne

Yvoir, Belgium

CHU d'Amiens

Amiens, France

Institut Bergonié

Bordeaux, France

Institut d'Hématologie de Basse Normandie

Caen, France

Key Dates

Start Date

October 3, 2012

Primary Completion Date

July 11, 2018

Completion Date

May 20, 2022

Last Updated

March 17, 2023

Enrollment

317

ACTUAL participants

Conditions

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

Interventions

Lenalidomide and GA101

DRUG