Carfilzomib With Bendamustine and Rituximab in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Part of paid clinical trials in Davis, California.

Sponsor
University of California, San Francisco
Study ID
NCT02187133
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Carfilzomib — DRUG
    Given IV; Dose Level (DL) Twice Weekly: DL -1 and DL 1: 15 mg/m\^2 Weekly: DL 1.5: 20,27,27 mg/m\^2, DL 2: 20,36,36 mg/m\^2, DL 3: 20,56,56 mg/m\^2 DL 4: 20,70,70 mg/m\^2
  • Bendamustine — DRUG
    Given IV; Dose Level (DL) DL -1: 75 mg/m\^2 DL 1,1.5, 2, 3, and 4: 90 mg/m\^2
  • Rituximab — DRUG
    Given IV; 375 mg/m\^2

Study Details

This study will be conducted as a Phase Ib, open-label, non-randomized, single-institution study to evaluate the safety and tolerability of carfilzomib in combination with bendamustine and rituximab in patients with relapsed or refractory NHL and to determine the recommended phase II dose and preliminary efficacy of this combination. The study will have two phases: a dose-escalation phase to determine the maximal tolerated dose of carfilzomib in this combination where participants will be monitored for toxicity, tolerability and response and a dose-expansion phase that will determine the preliminary efficacy in patients with Mantle cell lymphoma or any other disease subtype in which there is a preliminary efficacy signal observed.

Key Dates

Start date
May 5, 2015
Status verified
Apr 2021
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021

Study Design

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

Arms

  • Experimental: Treatment
    Patients receive carfilzomib IV over 30 minutes twice weekly on days 1, 2, 8, 9, 15, and 16 or weekly on days 2, 9, and 16; bendamustine hydrochloride IV over 60 minutes on days 1 and 2; and rituximab IV over 30-90 minutes on day 9 (course 1 only) and day 1 (subsequent courses). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximally tolerated dose (MTD) [ Time Frame: Up to 1 cycle (28 days per cycle) ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, DavisDavisCalifornia95616-
University of California, San DiegoSan DiegoCalifornia92093-
University of California, San FranciscoSan FranciscoCalifornia94143-

Find similar trials in Davis, CA

By research site
University of California, Davis· Davis, CAUniversity of California, San Diego· San Diego, CAUniversity of California, San Francisco· San Francisco, CA

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