Status:
COMPLETED
Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eisai Inc.
Genzyme, a Sanofi Company
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old...
Detailed Description
The Study Drugs: Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cell...
Eligibility Criteria
Inclusion
- Previously untreated AML and high-risk MDS (\>/= 10% blasts or \>/= IPSS intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.
- Age \>/= 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
- Adequate hepatic (serum total bilirubin \</= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) \</= 2.5 x ULN) and renal function (creatinine \</= 1.5 mg/dL).
- Sign written informed consent
Exclusion
- Cardiac ejection fraction \< 40%.
- Prior therapy with clofarabine or decitabine.
- Active and uncontrolled disease/infection as judged by the treating physician.
- Pregnancy
- Acute promyelocytic leukemia (APL).
- Women of childbearing potential and men who do not practice contraception.
- Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00778375
Start Date
October 1 2008
End Date
January 1 2015
Last Update
July 14 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030