NCT02055924: BIBLOS

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

Terminated Phase 1 Last updated 11 October 2018

What this trial tests

Phase 1 trial testing Ibrutinib and immunochemotherapies in B-cell Lymphoma in 85 participants. Terminated before completion.

Timeline

26 May 2014

Primary endpoint
1 December 2017

9 October 2018

Quick facts

Lead sponsor	The Lymphoma Academic Research Organisation
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	85
Start date	26 May 2014
Primary completion	1 December 2017
Estimated completion	9 October 2018
Sites	15 locations across Belgium, France

Drugs / interventions tested

• Ibrutinib and immunochemotherapies — full drug profile →

Conditions studied

• B-cell Lymphoma — all drugs for B-cell Lymphoma →

Sponsor

The Lymphoma Academic Research Organisation — full company profile →

Who can join

Adults 18 to 70, any sex, with B-cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regulation of B-Cell Receptor Signaling and Its Therapeutic Relevance in Aggressive B-Cell Lymphomas.
   Profitós-Pelejà N, Santos JC, Marín-Niebla A, Roué G, et al · · 2022 · cited 33× · PMID 35205606 · DOI 10.3390/cancers14040860
2. B-cell receptor pathway modulators in NHL.
   Blum KA. · · 2015 · cited 12× · PMID 26637705 · DOI 10.1182/asheducation-2015.1.82
3. Ibrutinib Associated with Rituximab-Platinum Salt-Based Immunochemotherapy in B-Cell Lymphomas: Results of a Phase 1b-II Study of the LYSA Group.
   Bonnet C, Dupuis J, Tilly H, Lamy T, et al · · 2022 · cited 1× · PMID 35406532 · DOI 10.3390/cancers14071761