MDACC Study Summary 2005-0647

Study Summary
No. 2005-0647:.......Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2005-0647

Study Title:	Randomized Phase 3 Trial of Decitabine Versus Patient's Choice with Physician's Advice of Either Supportive Care or Low-dose Cytarabine for the Treatment of Older Patients with Newly Diagnosed Acute Myeloid Leukemia

Physician

New Patient Referral



Name:	Hagop Kantarjian	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:	713-792-7305 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Patients receiving cytarabine: daily for 10 consecutive days repeated every 4 weeks, OR Patients receiving decitabine: once daily for 5 consecutive days repeated every 4 weeks.

Treatment Agents:	Cytarabine Decitabine	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find out if decitabine is more effective than either supportive care alone or low-dose cytarabine (ara-C) in keeping the disease from getting worse and improving the overall quality of life for AML patients 65 years old or older.

Study Objectives / Outcomes

Primary Objective
To compare the overall survival in patients 65 years and older who have newly diagnosed de novo or secondary AML and either poor- or intermediate-risk cytogenetics who are randomly assigned to receive either decitabine or patient's choice with physician's advice of either supportive care or low-dose cytarabine.

Secondary Objectives
The secondary objectives of the study are:

To compare complete remission rates between treatment arms.
To characterize and compare the incidence and severity of toxicities in the two treatment arms.

Tertiary Objectives
The tertiary objectives of the study are:

To compare cytogenetic complete remission rate between treatment arms.
To compare patient quality-of-life measurements between treatment arms.
To compare event-free survival and relapse-free survival between treatment arms.
To determine the population pharmacokinetics of decitabine in poor- or intermediate-risk cytogenetic patients 65 years and older with AML when given this treatment regimen.

Study Status Information



Study Activation / Registration Date:	11/30/2005

IRB Review and Approval Date:	09/21/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	480

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) Must sign an institutional review board/ethics committee-approved informed consent.

2) Must have a newly diagnosed, histologically confirmed de novo or secondary AML using the World Health Organization classification (e.g., >/= 20% blasts).

3) Must be at least 65 years of age and have either poor- or intermediate-risk cytogenetics as categorized by Southwest Oncology Group.

4) Must have a performance status of 0-2 on the Eastern Cooperative Oncology Group scale.

5) Must have adequate organ function, defined as: Hematology: WBC </= 40,000/mm; Hepatic: Bilirubin </= 1.5 times the upper limit of normal, AST or ALT </= 2.5 times the upper limit of normal; and Renal: Creatinine clearance (calculated by the Cockroft and Gault method) >/= 40 mL/min;

6) Must have a life expectancy of at least 12 weeks.

Exclusion Criteria:

1) Must not have acute promyelocytic leukemia (M3 classification).

2) Must not have t(8;21), inv(16) or t(15;17) karyotype abnormalities.

3) Must not have known CNS leukemia.

4) Must not have any other active systemic malignancies.

5) Must not have unstable angina or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.

6) Must not have inaspirable bone marrow.

7) Must not have received previous chemotherapy (except hydroxyurea), including azacytidine (Vidaza^TM), cytarabine or decitabine, for any myeloid disorder.

8) Must not have chronic respiratory disease that requires continous oxygen use.

9) Must not have received any experimental drug within 4 weeks of randomization.

10) Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.

11) Must not have any concomitant medical or psychiatric disorders incompatible with the study (at the discretion of the investigator).

12) Must not have any comorbidity that causes organ dysfunction that is not related to leukemia.

13) Must not have an uncontrolled active infection(s) requiring IV antibiotics.

14) Must not have known HIV.

15) Must not have had radiotherapy for extramedullary disease within 2 weeks prior to study randomization.

Links

Registration Number: NCT00260832
Study Information on Clinical Trials Registry (clinicaltrials.gov)