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Study Summary
No. 2012-1064:.......Leukemia......Nitin Jain......Leukemia
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Study Summary Title
Study Summary
Number:		2012-1064
Study Title:Phase I/II Study of Decitabine (DAC) followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia
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Physician New Patient Referral
Name:Nitin JainPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-6080
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase I/Phase IIReturn
Visit:
Treatment
Agents:		Clofarabine
Cytarabine
Decitabine
Idarubicin		Home Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:		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.
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Study Objectives / Outcomes
Phase I
Primary:
To determine the maximal tolerated dose (MTD) of clofarabine to be used in portion II of the study

Phase II
Primary:
To determine the response rate of the DAC-CIA regimen

Secondary:
A) To determine the toxicity of the combination regimen
B) To determine the disease-free survival (DFS) and overall survival (OS) rates
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:02/20/2013
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
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 </=2 at study entry.

5) 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

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
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Links
Registration Number: NCT01794702
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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