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Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma

NCT02269085 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-02-28

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of carfilzomib and ibrutinib that can be given to patients with relapsed or refractory MCL.

Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease.

This is an investigational study. Ibrutinib is FDA approved and commercially available to treat MCL and chronic lymphocytic leukemia (CLL). Carfilzomib is FDA approved and commercially available to treat certain types of multiple myeloma. Giving carfilzomib to patients with MCL is investigational. The combination of ibrutinib and carfilzomib is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 35 participants will be enrolled on this study. All will be enrolled at MD Anderson.

Conditions

Interventions

DRUG

Ibrutinib

Phase I Starting Dose: 420 mg by mouth daily on Days 1 - 28 of a 28-day cycle. Phase II Starting Dose: MTD from Phase I.

DRUG

Carfilzomib

Phase I Starting Dose: 20 mg/m2 by vein on Days 1, 2, 8 ,9, 15 and 16 in Cycles 1 - 12, and Days 1,2 and 15,16 of Cycle 13 and beyond. Phase II Starting Dose: MTD from Phase I.

BEHAVIORAL

Phone Calls

Study staff calls participant after end-of-dosing visit every 6 months for 5 years. These calls should take about 2-3 minutes.

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-20
Primary Completion
2018-05-29
Completion
2018-05-29
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 NCT02269085 on ClinicalTrials.gov