Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome

In brief

The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.

Key facts

Study ID

NCT00088218

Run by

M.D. Anderson Cancer Center

People needed

95

Starts

2004-07-01

Expected to finish

2008-02-01

Last updated by the study team

2012-08-07

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 International Prognostic Scoring System (IPSS) intermediate-2). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
• Age > 60 years.
• Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
• Sign a written informed consent form.
• Adequate liver function (total bilirubin < 2mg/dL,serum glutamic pyruvic transaminase (SGPT) or Serum glutamic oxaloacetic transaminase (SGOT) < x 4 upper limit of normal (ULN)) and renal function (serum creatinine < 2mg/dL).

You may not qualify if…

• Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination.

Where it is running

• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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