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

NCT02187133 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Carfilzomib

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

DRUG

Bendamustine

Given IV; Dose Level (DL) DL -1: 75 mg/m\^2 DL 1,1.5, 2, 3, and 4: 90 mg/m\^2

DRUG

Rituximab

Given IV; 375 mg/m\^2

Sponsors & Collaborators

Principal Investigators

  • Charalambos Andreadis, M.D. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-05
Primary Completion
2021-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT02187133 on ClinicalTrials.gov