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

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT02055924
Phase
PHASE1
Status
Terminated

Conditions

  • B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 26, 2014
Status verified
Oct 2018
Primary completion
Dec 1, 2017
Completion
Oct 9, 2018

Study Design

Enrollment
85 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib and immunochemotherapies
    Combination of immunochemotherapies (R-DHAP or R-DHAOx) and ibrutinib

Primary Outcome Measure

The primary endpoint is the incidence rate of DLTs at each dose level on cycle 1 [ Time Frame: 21 days ]

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