Last updated on July 2016

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


Brief description of study

This is an open label, multicenter, fixed dose and dose escalation, phase I/II study. The study will be conducted into 2 steps. The first one will be to ensure the safety of the combination of Obinutuzumab (GA101) and Ibrutinib at fixed doses. A total of 9 patients will be included in this first step (step A) with grouped inclusions of three patients (a safety evaluation will be performed at each inclusion of 3 patients). The second step (step B) will be conducted if no unacceptable toxicity is observed during the first step and 24 new patients will be included in the step B. The aim of the second step is to determine the MTD of the GDC-0199 in combination of GA101 and Ibrutinib (both respecting the previous doses) by using a Continual Reassessment Method.

Detailed Study Description

The study will be conducted into 2 steps for respecting the optimal safety of the OASIS trial: Step A : The primary objective of step A is to evaluate the safety of the combination of GA101 + Ibrutinib at fixed doses (560 mg per day of Ibrutinib + 1000 mg of GA101), in patients with relapsed or refractory Mantle Cell Lymphoma (MCL). Secondary objectives: - To describe the efficacy of the combination of GA101 and Ibrutinib in terms of clinical benefits response (overall response rate, complete response rate, partial response rate Cheson 99 and 07 criteria and Working Group Revised Response Criteria for Malignant Lymphomas 14), overall survival, progression free survival. - To describe the safety and tolerability of the combination of GA101 and Ibrutinib - To establish a bio-bank to explore biomarkers and mechanisms of action including resistance Step B : This study will be performed conditionally to the observation of no unacceptable toxicity in patients included in the step A. The primary objective of this step is to determine the maximal tolerated dose (MTD) of the GDC-0199 in addition to the GA101 and Ibrutinib in relapsed refractory MCL patients by using a Continual Reassessment Method (CRM). Secondary objectives: - To describe the efficacy of the combination GA101, Ibrutinib and GDC-0199 in terms of clinical benefits response (overall response rate, complete response rate, partial response rate Cheson 99 and 07 criteria and Working Group Revised Response Criteria for Malignant Lymphomas 14), overall survival, progression-free survival. - To describe the safety and tolerability of the novel combination of GDC-0199, GA101 and Ibrutinib - To establish a bio-bank to explore biomarkers and mechanism of action including resistance

Clinical Study Identifier: NCT02558816

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

René-Olivier Casasnovas, Pr

CHU de Dijon
Dijon, France
  Connect »

Franck Morschhauser, Pr

H pital Claude Huriez - CHRU de Lille
Lille, France
  Connect »

Guillaume Cartron, Pr

H pital Saint Eloi
Montpellier, France
  Connect »

Steven LE GOUILL, Pr

CHU de Nantes
Nantes, France
  Connect »

Krimo BOUABDALLAH, Pr

H pital du Haut L v que
Pessac, France
  Connect »

Simon RULE, Pr

Derriford Hospital _ Plymouth Hospitals NHS Trust
Plymouth, United Kingdom
  Connect »

Andrew DAVIES, Dr

University of Southampton
Southampton, United Kingdom
  Connect »