Ruxolitinib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT01895842|
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Ruxolitinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Ruxolitinib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||April 2, 2019|
|Actual Study Completion Date :||April 2, 2019|
Part 1: Dose of ruxolitinib received will depend when patient joined study. The first group of patients receive the lowest dose of ruxolitinib. Starting dose level for Part 1, 5 mg by mouth twice a day for a 28 day cycle. The second group of patients receive the lowest dose of ruxolitinib for 1 cycle and if no intolerable side effects are seen, the dose will increase to the next higher dose for Cycles 2 and beyond. The third group of patients receive the higher dose taken by the second group for 1 cycle and if no intolerable side effects are seen, the dose will be increased for Cycles 2 and beyond. The fourth group of patients take the higher dose taken by the third group for 1 cycle and if no intolerable side effects are seen, the dose will increase to the next higher dose for Cycles 2 and beyond.
If patients enrolled in Part 2, they will receive ruxolitinib at the highest dose that was tolerated in Part 1.
Starting dose level for Part 1: 5 mg by mouth twice a day for a 28 day cycle.
Starting dose level for Part 2: Maximum tolerated dose from Part 1.
- Maximum Tolerated Dose (MTD) of Ruxolitinib [ Time Frame: 28 days ]Maximum tolerated dose (MTD) is the maximum dose at which <33% of patients experience a dose limiting toxicity (DLT). Dose limiting toxicity defined as any grade 3 or higher non-hematologic toxicity.
- Number of Participants with Response of Ruxolitinib [ Time Frame: 8 weeks ]Criteria for response follows the modified International Working Group (IWG) response criteria for altering natural history of MDS defined as: Complete Remission, Partial Remission, Stable Disease, Cytogenetic Response, Disease Progression.
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): NCT01895842
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Guillermo Garcia-Manero, MD||M.D. Anderson Cancer Center|