Overview

Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
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 or older. The safety of this treatment will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Eisai Inc.
Genzyme, a Sanofi Company
Treatments:
Azacitidine
Clofarabine
Cytarabine
Decitabine
Criteria
Inclusion Criteria:

1. 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.

2. Age >/= 60 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status
4. Adequate hepatic (serum total bilirubin transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) ULN) and renal function (creatinine
5. Sign written informed consent

Exclusion Criteria:

1. Cardiac ejection fraction < 40%.

2. Prior therapy with clofarabine or decitabine.

3. Active and uncontrolled disease/infection as judged by the treating physician.

4. Pregnancy

5. Acute promyelocytic leukemia (APL).

6. Women of childbearing potential and men who do not practice contraception.

7. Women of childbearing potential and men must agree to use contraception prior to study
entry and for the duration of study participation.