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

Sponsor
Swiss Cancer Institute
Study ID
NCT02356458
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    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
  • bortezomib — DRUG
    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

Study Details

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

Key Dates

Start date
Aug 31, 2015
Status verified
Feb 2022
Primary completion
Mar 30, 2021
Completion
Mar 30, 2021

Study Design

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

Arms

  • Experimental: Ibrutinib & Bortezomib
    Combination therapy (trial treatment of ibrutinib in combination with bortezomib) followed by ibrutinib maintenance therapy

Primary Outcome Measure

Phase I: Dose limiting toxicity (DLT) observed during the first cycle of trial treatment [ Time Frame: At day 8, 14, 21 during cycle 1 (1 cycle = 21 days) ]

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