MDACC Study Summary 2012-1017

Study Summary
No. 2012-1017:.......Leukemia......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2012-1017

Study Title:	A RANDOMIZED PHASE II STUDY OF TWO SCHEDULES OF DECITABINE FOR FRONTLINE THERAPY OF OLDER OR UNFIT PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML)

Physician

New Patient Referral



Name:	Farhad Ravandi-Kashani	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0394 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Decitabine	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to compare how well 2 different dosing schedules of decitabine may help control AML. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.

Study Objectives / Outcomes

Primary: Compare the response rates of two schedules of decitabine in patients with AML 60 and older than 60 and/or unfit for standard cytotoxic chemotherapy.

Secondary: Compare response durations, survivals and side effects of the two schedules.

Tertiary: To examine the correlation of a number of biological and pharmacodynamics correlates with response to therapy including global and gene-specific methylation, specific somatic gene mutations, micro-RNA, and immune effector function

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/05/2013

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

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) Patients with previously untreated AML (by the WHO criteria, i.e. >/= 20% blasts) Prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. Patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.

2) Patients >/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by Kantarjian's score (Appendix D) Patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.

3) Performance 0-3 (ECOG).

4) Adequate liver function (Total bilirubin of < 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or Gilbert's syndrome and renal function (creatinine < 2.5 mg/dl).

5) Signed informed consent

Exclusion Criteria:

1) Nursing and pregnant females. Female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Negative urine pregnancy test (women of childbearing potential)

2) Active and uncontrolled infections.

3) Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.

Links

Registration Number: NCT01786343
Study Information on Clinical Trials Registry (clinicaltrials.gov)