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COMPLETED
NCT02558816
PHASE1/PHASE2

A Trial of Obinutuzumab,GDC-0199 Plus Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma Patients

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

This is an open label, multicenter, fixed dose and dose escalation, phase I/II study. The study will be conducted in 3 steps. The first one (step A) will be to ensure the safety of the combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses in patients with relapsed or refractory Mantle Cell Lymphoma (MCL). A total of 9 patients have been included in the first step with grouped inclusions of three patients (safety evaluation performed at each inclusion of 3 patients). No unacceptable toxicity has been observed during step A, thefore the second step (step B) was initiated. The aim of the second step was to determine the MTD of the GDC-0199 (400-600-800mg/d) in combination of GA101 and Ibrutinib (both respecting the previous doses) by using a Continual Reassessment Method. This dose escalation method was used until the 12th patient (3 patients included at 400mg/d of GDC-0199-(no DLT), 3 at 600mg/d- (no DLT) and 6 at 800mg/d, (not DLT reported so far). Once the last patient of the 800mg cohort is evaluated for DLT, all other patients will be treated at the dose of 400mg/d of GDC-0199. The third step (step C) for untreated patients will be conducted at the dose of 400mg/d of GDC-0199. The aim of step C is to confirm the safety profile of the GA101 + Ibrutininb + GDC-199 combination according to step B result. 15 patients will be included in this step.

Official title: A Phase I/II Trial of Obinutuzumab, ABT-199 (GDC-0199) Plus Ibrutinib in Relapsed / Refractory Mantle Cell Lymphoma Patients

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2015-10-14

Completion Date

2025-05-13

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DRUG

Ibrutinib + GA101 +GDC-0199

Step A : 9 patients receive the combination of Ibrutinib + GA101 Step B : 24 patients receive the combination of Ibrutinib + GA101 + GDC-0199 Step C : 15 untreated patients receive the combination of Ibrutinib + GA101 + GDC-0199

Locations (9)

CHU Angers

Angers, France

CHU de Dijon

Dijon, France

Hôpital Claude Huriez - CHRU de Lille

Lille, France

Hôpital Saint Eloi

Montpellier, France

CHU de Nantes

Nantes, France

Hôpital du Haut Lévêque

Pessac, France

CHU Rennes

Rennes, France

Derriford Hospital _ Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

University of Southampton

Southampton, United Kingdom