Bruton's Tyrosine Kinase (BTK) Inhibition in B-cell Lymphomas

Summary

This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended dose by assessing the maximum tolerated dose (MTD), safety and efficacy of ibrutinib in combination with R-DHAP (Group A/Abis) or R-DHAOx (Group B/Bbis) for patients with B-cell malignancies. This dose escalation will be followed by an exploratory expansion phase in 3 groups of 12 patients each (Group A/Abis, Group B/B bis and Group C). During Part 1 Dose Escalation, the "3+3" design will be applied. Three doses of ibrutinib (280, 420 and 560 mg) will be examined sequentially in each cohort by the Dose Escalation Committee. Dose escalation will begin at dose level 1 = 420 mg. The dose escalation will be performed for two types of associations in five separate groups : * Group A : ibrutinib D1-D21+ R-DHAP * Group B : ibrutinib D1-D21 R-DHAOx * Group Abis : ibrutinib D5-D18+ R-DHAP * Group Bbis : ibrutinib D5-D18 R-DHAOx This dose escalation will be followed by an exploratory expansion phase in the group Bbis plus a new group including only mantle cell lymphoma (MCL) in first line patients: group C. Patients included in the Group C will receive ibrutinib in combination with R-DHAP or R-DHAOx according to the choice of the local investigator at time of inclusion of each patient.

Timeline

Start

2014-05-26

Primary completion

2017-12-01

Completion

2018-10-09

Drugs

Indications