Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT02269085|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Ibrutinib Drug: Carfilzomib Behavioral: Phone Calls||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Trial of Ibrutinib (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma|
|Actual Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Ibrutinib + Carfilzomib
Phase I: Ibrutinib administered by mouth daily at 420 or 560 mg on Days 1 - 28 of a 28-day cycle. Carfilzomib administered by vein 20/27 mg/m^2, 20/36 mg/m^2, 20/45 mg/m^2 or 20/56 mg/m^2 on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle for Cycles 1- 12 and on Days 1, 2, 15 and 16 for Cycle 13 and higher.
Phase II: Once the MTD has been established 5 additional patients treated at the MTD to a maximum of 35 patients with MCL.
Study staff calls participant after end-of-dosing visit every 6 months for 5 years.
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.
Other Names:Drug: Carfilzomib
Behavioral: Phone Calls
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.
Study staff calls participant after end-of-dosing visit every 6 months for 5 years. These calls should take about 2-3 minutes.
- Maximum Tolerated Dose (MTD) of Carfilzomib When Given With Ibrutinib [ Time Frame: 28 days ]MTD is defined as highest dose level in which 6 patients have been treated with less than 2 instances of dose limiting toxicity (DLT). DLT assessed during the first course of each cohort (28 days), and refers to a study drug related or possibly related event which meets one of the following criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
- Response Rate of Carfilzomib When Given With Ibrutinib [ Time Frame: Assessed after two 28 day cycles ]Response definitions for measurable disease used from Revised International Workshop Standardized Response Criteria for non-Hodgkin's Lymphoma42. Patients assessed for response after every 2 cycles of therapy. Complete response (CR) defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response (PR) defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. Stable disease (SD) determined when participant fails to attain criteria needed for a CR or PR, but does not fulfill those for progressive disease. Progressive disease (PD) considered when lymph nodes measure abnormally, if the long axis is more than 1.5 cm regardless of the short axis. If lymph node has a long axis of 1.1 to 1.5 cm, it should only be considered abnormal if its short axis is more than 1.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269085
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hun J. Lee, MD||M.D. Anderson Cancer Center|