B-cell Lymphoma Clinical Trial
Official title:
A Phase Ib Study of Ibrutinib Combined With R-DHAP or R-DHAOx in Patients With B-cell Lymphomas
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.
The primary objective of this study is to determine the recommended dose of ibrutinib when administered in combination with R-DHAP (rituximab + dexamethasone + cytarabine + cisplatin) or with R-DHAOx (rituximab + dexamethasone + cytarabine + oxaliplatin) in patients with relapsed or refractory B-cell malignancies eligible for autologous stem cell transplantation (ASCT) by assessing the maximum tolerated dose (MTD) observed during the dose escalation part of the study. Assessment of the MTD will be performed by the analysis of the dose-limiting toxicities (DLTs). ;
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