Overview

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

Status:
Completed
Trial end date:
2017-06-28
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Clofarabine
Cytarabine
Fludarabine
Fludarabine phosphate
Idarubicin
Vidarabine
Criteria
Inclusion Criteria:

1. Sign an Institutional Review Board (IRB)-approved informed consent document.

2. Age 18 to 60. Patients above the age of 60 only with principal investigator (PI)
approval

3. Diagnosis of newly diagnosed AML [other than acute promyelocytic leukemia (APL)] or
high-risk (intermediate-2 or high by International Prostate Symptom Score (IPSS) or >
10% blasts, including CMML) MDS. Prior therapy with hydrea and the use of a single or
a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to
start of study therapy is allowed. Prior therapy for MDS or other AHD is not allowed.

4. Eastern Cooperative Oncology Group (ECOG) performance status of
5. Organ function as defined below (unless due to leukemia): Serum creatinine Total bilirubin limit of normal (ULN) or
6. Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days and must agree to practice acceptable contraceptive methods. Men must
agree not to father a child and agree to use a condom if his partner is of child
bearing potential.

7. Cardiac ejection fraction >/= 40% (by either cardiac echo or multiple gated
acquisition scan (MUGA) scan). Documentation of recent ( outside reports is acceptable.

Exclusion Criteria:

1. Breast feeding females

2. Patients with uncontrolled active infections (viral, bacterial, and fungal are not
eligible).

3. Patients with active secondary malignancy will not be eligible.