Status:
COMPLETED
A Study of Low-Dose Decitabine in Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eisai Inc.
Conditions:
Acute Lymphocytic Leukemia
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the safety of decitabine in patients with acute lymphocytic leukemia. Upon agreement of the patient, additional blood and bone marrow samples to be ...
Detailed Description
Decitabine is a potent hypomethylating agent with clinical activity in myelodysplastic syndromes (MDS), and acute and chronic myelogenous leukemia (CML). In vitro, decitabine induces loss of cell viab...
Eligibility Criteria
Inclusion
- Patients with refractory or relapsed acute lymphocytic leukemia (ALL).
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas MD Anderson Cancer Center (UTMDACC).
- Patients of any age are eligible.
- Patients must have been off chemotherapy for 1 week prior to entering this study and recovered from the toxic effects (\< grade 2) of that therapy, unless there is evidence of rapidly progressive disease. Use of high dose steroids with dexamethasone is allowed during the first 2 courses of therapy. Imatinib mesylate (Gleevec) must be stopped 1 week prior to entering this study.
- Adequate liver function (bilirubin of \< 3 mg/dL, serum glutamate pyruvate transaminase (SGPT) \< 5 x ULN) and renal function (creatinine \< 3mg/dL) unless proven to be related to disease infiltration.
- Women of childbearing potential must practice contraception. Child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. Men and women must continue birth control for the duration of the trial.
Exclusion
- 1\) Nursing and pregnant females are excluded.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00349596
Start Date
July 1 2006
End Date
October 1 2014
Last Update
October 15 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030