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

Completed · Phase 2

Conditions studied: Leukemia, AML, MDS, CML

In brief

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.

Key facts

Study ID

NCT01019317

Run by

M.D. Anderson Cancer Center

People needed

151

Starts

2009-11-01

Expected to finish

2012-09-01

Last updated by the study team

2016-03-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign an Internal Review Board (IRB)-approved informed consent document.
• Age >/= 12 years.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
• Organ function as defined below (unless due to leukemia):
• i. Serum creatinine </= 3 mg/dL; ii. Total bilirubin </= 3 mg/dL; iii. Alanine aminotransferase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) </= 5 times upper limit of normal (ULN) or </= 10 times ULN if related to disease.
• 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.

You may not qualify if…

• Pregnant or breastfeeding females.
• Diagnosis of acute promyelocytic leukemia (M3).

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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