Phase I/II Carfilzomib Plus Lenalidomide and Rituximab in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01729104
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Carfilzomib — DRUG
    Phase I Starting Dose: 20 mg/m2 by vein on Days 1, 2, 8, 9, 15, and 16 of Cycles 1-12. Cycles 13 and beyond, dose given on Days 1, 2, 15, and 16. Phase II Starting Dose: MTD from Phase I.
  • Lenalidomide — DRUG
    Phase I and Phase II: 20 mg by vein on Days 1-21 of each cycle.
  • Rituximab — DRUG
    Phase I and II: 375 mg/m2 by vein on Days 1, 8, 15, and 22 of Cycle 1 and 2. For Cycles 3 - 12, given on Day 1. For Cycles 13 and beyond, given on Day 1 every other cycle for up to 24 months.

Study Details

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given in combination with lenalidomide and rituximab to patients with relapsed or refractory B-cell non-hodgkin lymphoma. The goal of Part 2 of this study is to learn if the drug combination can help to control B-cell non-hodgkin lymphoma. The safety of this drug combination will be studied in both parts. Carfilzomib is designed to keep cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer cells to die. It is also designed to cause the immune system to attack cancer cells.

Key Dates

Start date
Apr 25, 2013
Status verified
Oct 2019
Primary completion
Oct 3, 2018
Completion
Oct 3, 2018

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Carfilzomib + Lenalidomide + Rituximab
    Phase I: Four primary dose levels of carfilzomib plus lenalidomide (carfilzomib 20 mg/27 mg + lenalidomide 20 mg, carfilzomib 20 mg/36 mg + lenalidomide 20 mg, carfilzomib 20mg/45 mg + lenalidomide 20 mg, carfilzomib 20 mg/56 mg + lenalidomide 20 mg,) evaluated with a fixed dose of rituximab (375 mg/m2 weekly for 4 weeks). Alternate dose levels using 15 mg of lenalidomide in combination with carfilzomib and rituximab evaluated if MTD is exceeded with 20 mg of lenalidomide.
  • Experimental: Phase II: Mantle Cell Lymphoma Group
    Phase II: Patients enrolled at recommended dose level (MTD) of Carfilzomib established in Phase I of the study. Phase II Lenalidomide Dose: 20 mg by vein on Days 1-21 of each cycle. Phase II Rituximab Dose: 375 mg/m2 by vein on Days 1, 8, 15, and 22 of Cycle 1 and 2. For Cycles 3 - 12, given on Day 1. For Cycles 13 and beyond, given on Day 1 every other cycle for up to 24 months.
  • Experimental: Phase II: Follicular, Marginal Zone, DLBCL Group
    Group consists of : Patients with follicular lymphoma (FL) grade 1 - 3, marginal zone lymphoma (MZL), or non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL). Phase II: Patients enrolled at recommended dose level (MTD) of Carfilzomib established in Phase I of the study. Phase II Lenalidomide Dose: 20 mg by vein on Days 1-21 of each cycle. Phase II Rituximab Dose: 375 mg/m2 by vein on Days 1, 8, 15, and 22 of Cycle 1 and 2. For Cycles 3 - 12, given on Day 1. For Cycles 13 and beyond, given on Day 1 every other cycle for up to 24 months.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Carfilzomib and Lenalidomide in Combination With Rituximab [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies