Bortezomib in Combination With Ibrutinib in Ibrutinib Relapsed Mantle Cell Lymphoma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03617484
Phase
PHASE2
Status
Withdrawn

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Bortezomib — DRUG
    Bortezomib will be administered subcutaneously at a dose of 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each 21-day cycle.
  • Ibrutinib — DRUG
    Ibrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle.

Study Details

This is a phase II study to evaluate the efficacy of ibrutinib in combination with bortezomib in in MCL (mantle cell lymphoma) patients who relapsed on single agent ibrutinib.

Key Dates

Start date
Jul 31, 2020
Status verified
Jun 2020
Primary completion
Jan 31, 2023
Completion
Jul 31, 2030

Study Design

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

Arms

  • Experimental: Bortezomib + Ibrutinib
    Ibrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle. Bortezomib will be administered subcutaneously at a dose of 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each 21-day cycle.

Primary Outcome Measure

The proportion of participants that respond to treatment at 6 months [ Time Frame: 6 Months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48187-

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By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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