Status:
COMPLETED
Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia. Th...
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 3 groups of 6 participants will be enrolled in...
Eligibility Criteria
Inclusion
- Sign an IRB-approved informed consent document.
- Age \>/= 18 years and \<65 years.
- Diagnosis of AML \[other than acute promyelocytic leukemia\] with refractory/relapsed disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE: Patients with AML arising from prior MDS or MPN would be eligible even if they have not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed
- ECOG performance status of \</=2 at study entry.
- Organ function as defined below (unless due to leukemia):Serum creatinine \</= 3 mg/dL;Total bilirubin \</= 2.5 mg/dL; ALT (SGPT) \</= 3 x ULN or \</= 5 x ULN if related to disease
- Cardiac ejection fraction ≥ 40% (by either cardiac ECHO or MUGA scan)
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
Exclusion
- Breast feeding women
- Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
- Patients with active secondary malignancy will not be eligible unless approved by the PI.
- NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study
Key Trial Info
Start Date :
February 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01794702
Start Date
February 20 2013
End Date
January 11 2018
Last Update
May 30 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030