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

NCT02055924 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-10-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ibrutinib and immunochemotherapies

Combination of immunochemotherapies (R-DHAP or R-DHAOx) and ibrutinib

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Gilles SALLES, PhD · CHU Lyon - Sud - LYSA

  • Christophe BONNET, MD · CHU Liège - LYSA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-26
Primary Completion
2017-12-01
Completion
2018-10-09

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02055924 on ClinicalTrials.gov