Overview

Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Cytarabine
Fludarabine
Fludarabine phosphate
Vidarabine
Criteria
Inclusion Criteria:

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

2. Age >/= 12 years.

3. Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with
refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not
a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or
high by IPSS or >/=10% blasts) MDS will also be eligible. Patients with chronic
myeloid leukemia (CML) in blast crisis will be eligible as well.

4. Eastern Cooperative Oncology Group (ECOG) performance status of
5. Organ function as defined below (unless due to leukemia):

i. Serum creatinine aminotransferase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) limit of normal (ULN) or
6. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 7 days . Men must agree not to father a child and agree to use a condom if
his partner is of child bearing potential.

Exclusion Criteria:

1. Pregnant or breastfeeding females.

2. Diagnosis of acute promyelocytic leukemia (M3).