Overview

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

Status:
Completed
Trial end date:
2018-01-11
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Azacitidine
Clofarabine
Cytarabine
Decitabine
Idarubicin
Criteria
Inclusion Criteria:

1. Sign an IRB-approved informed consent document.

2. Age >/= 18 years and <65 years.

3. 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

4. ECOG performance status of
5. Organ function as defined below (unless due to leukemia):Serum creatinine mg/dL;Total bilirubin to disease

6. Cardiac ejection fraction ≥ 40% (by either cardiac ECHO or MUGA scan)

7. 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.

Exclusion Criteria:

1. Breast feeding women

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

3. Patients with active secondary malignancy will not be eligible unless approved by the
PI.

4. 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