MedTrace Logo

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

NCT01729104 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-10-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Carfilzomib

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.

DRUG

Lenalidomide

Phase I and Phase II: 20 mg by vein on Days 1-21 of each cycle.

DRUG

Rituximab

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.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Onyx Therapeutics, Inc.

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Hun J. Lee, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-25
Primary Completion
2018-10-03
Completion
2018-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01729104 on ClinicalTrials.gov