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Combination of Ibrutinib and Bortezomib to Treat Patients With Mantle Cell Lymphoma

NCT02356458 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-03-11

No results posted yet for this study

Summary

Mantle cell lymphoma (MCL) remains an incurable disease with frequent relapses and no standard therapeutic options in case of relapse. Prolongation of remissions or induction of longer remissions is therefore crucial. Recently, a synergistic increase in the proteasomal inhibition of ibrutinib in both bortezomib-sensitive and refractory MCL cells was shown. These findings, along with the reported single agent activities of both drugs and the non-overlapping toxicities, are the rationale to combine ibrutinib and bortezomib in MCL in this trial

Conditions

Interventions

DRUG

Ibrutinib

Combination therapy: Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Ibrutinib: p.o daily; Phase I: according to DL; Phase II: RP2D established in phase I Maintenance therapy: p.o daily: 560 mg

DRUG

bortezomib

Combination therapy: Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Injection of Bortezomib (s.c.), dose of 1.3 mg/m2 on day 1, 4, 8, 11

Sponsors & Collaborators

  • European Mantle Cell Lymphoma Network

    collaborator OTHER

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Urban Novak, PD Dr. med. · University Hospital Bern - Inselspital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT02356458 on ClinicalTrials.gov