A Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02973711|
Recruitment Status : Withdrawn (lack of funding)
First Posted : November 25, 2016
Last Update Posted : February 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Chronic Myeloid||Drug: Nilotinib Drug: Ruxolitinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Ruxolitinib in Combination With Nilotinib in Patients With Chronic Phase CML Who Have Achieved a Complete Hematologic Remission, Complete Cytogenetic Remission, and Major Molecular Remission, But Not a Complete Molecular Remission on a Tyrosine Kinase Inhibitor Alone.|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Nilotinib + Ruxolitinib
The first part of the trial will be Phase I and will enroll 25 participants. Participants will receive nilotinib BID and either 10, 15 or 20 mg of ruxolitinib BID. Maximum tolerated dose (MTD) of ruxolitinib will be determined.
The second part of the trial will be a Phase II and will enroll 25 subjects. Participants will receive nilotinib and the MTD of ruxolitinib.
Nilotinib 300 mg BID
Ruxolitinib, 10, 15 or 20mg BID
- Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib [ Time Frame: 2 Years ]Maximum Tolerated Dose (MTD) of ruxolitinib when combined with nilotinib
- The number of patients that achieve a Complete Molecular Response (CMR) [ Time Frame: 2 Years ]CMR is defined as an absence of the BCR-ABL1 transcript by qPCR performed on peripheral blood or bone marrow aspirate.
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): NCT02973711
|United States, Michigan|
|The University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Patrick Burke, M.D.||University of Michigan Rogel Cancer Center|