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A Trial of Obinutuzumab,GDC-0199 Plus Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma Patients
Sponsor: Nantes University Hospital
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
Conditions
Interventions
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