Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

Completed · Phase 1/Phase 2

Conditions studied: Leukemia

In brief

The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia. The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied. Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.

Key facts

Study ID

NCT01794702

Run by

M.D. Anderson Cancer Center

People needed

65

Starts

2013-02-20

Expected to finish

2018-01-11

Last updated by the study team

2019-05-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Sign an IRB-approved informed consent document.
• Age >/= 18 years and <65 years.
• Diagnosis of AML [other than acute promyelocytic leukemia] with refractory/relapsed disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE: Patients with AML arising from prior MDS or MPN would be eligible even if they have not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed
• ECOG performance status of </=2 at study entry.
• Organ function as defined below (unless due to leukemia):Serum creatinine </= 3 mg/dL;Total bilirubin </= 2.5 mg/dL; ALT (SGPT) </= 3 x ULN or </= 5 x ULN if related to disease
• Cardiac ejection fraction ≥ 40% (by either cardiac ECHO or MUGA scan)
• Women of childbearing potential 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…

• Breast feeding women
• Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
• Patients with active secondary malignancy will not be eligible unless approved by the PI.
• NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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