MDACC Study Summary 2006-0813

Study Summary
No. 2006-0813:.......Leukemia......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2006-0813

Study Title:	Prospective evaluation of standard chemotherapy regimen of Idarubicin and Cytarabine in patients with newly diagnosed 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:	2 to 3 times weekly for the first 2 months, then weekly while receiving therapy

Treatment Agents:	Cytarabine Idarubicin	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	7 to 28 days


Description/ Intervention:	The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.

Study Objectives / Outcomes

To determine the complete response (CR) rate, event-free survival (EFS)

and overall survival (OS) of patients with newly diagnosed acute myeloid

leukemia (AML) receiving standard combination chemotherapy with

Idarubicin and cytarabine.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	11/01/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

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) Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.

2) Patients aged 15 to 75 years are eligible. Patients must be chemo-na�ve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusions, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .

3) ECOG PS of 0, 1, 2, or 3 at screening.

4) Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) </= 3x ULN

5) Ability to understand and provide signed informed consent.

Exclusion Criteria:

1) Subjects with Acute Promyelocytic Leukemia (APL).

2) Presence of active systemic infection.

3) Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.

4) Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.

Links

Registration Number: NCT00422591
Study Information on Clinical Trials Registry (clinicaltrials.gov)