Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Completed · Phase 2
Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome
In brief
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 or older. The safety of this treatment will also be studied.
Key facts
- Study ID
- NCT00778375
- Run by
- M.D. Anderson Cancer Center
- People needed
- 122
- Starts
- 2008-10-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-07-14
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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