Status:
COMPLETED
Ruxolitinib for Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Incyte Corporation
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib that can be given to patients with low or intermediate-1 risk MDS. The safety of this drug will also be st...
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 4 groups of 3-6 participants will be enrolled ...
Eligibility Criteria
Inclusion
- Patients with previously treated low or intermediate-1 risk MDS by the IPSS classification (this is defined in table 1)
- Patients must have one of the following: elevated b2-microglobulin levels (defined as 2 times compared to normal), carry a JAK2 mutation, or presence of phosphorylated p65 NF-kB component in at least 5% of bone marrow cells.
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC.
- Age \>/= 18 years old
- Prior therapy with growth factor support, lenalidomide, 5-azacytidine, decitabine or other investigational agents are allowed. A four week wash out period will be required before receiving study medication.
- Patients must have the following non-hematologic values Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \</= 2.5 x Upper Limit of Normal (ULN) or \</= 5.0 x ULN if hepatic involvement is present; Serum bilirubin \</= 2 x ULN; Serum creatinine \</= 2 x ULN or 24-hour creatinine clearance \>/= 60 ml/min
- Patients with Childbearing potential must agree to use appropriate forms of birth control
Exclusion
- Previously untreated low or intermediate-1 risk MDS patients because there are approved therapies for these patients.
- Uncontrolled undercurrent illness that in the opinion of the treating physician would contraindicate the use of the drug.
- Patients with active infections including uncontrolled HIV infection, active hepatitis B, C, or any other symptomatic systemic infection requiring active therapy will be excluded from study
- Patients receiving potent CYP3A4 (such as but not limited to boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) inhibitors will be excluded from the study.
- Women who are pregnant or lactating.
- Patients with a white blood cell count of more than 30x10\^3 K/uL will not be eligible for this study.
- Patients that have received prior allogeneic stem cell transplantation are excluded from this study.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 2 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01895842
Start Date
February 1 2014
End Date
April 2 2019
Last Update
February 28 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030