MDACC Study Summary ID03-0181

Study Summary
No. ID03-0181:.......Leukemia......Stefan Faderl......Leukemia

Study Summary Title



Study Summary Number:	ID03-0181

Study Title:	A Prospective Randomized Phase I/II Study of Clofarabine and Ara-C vs Clofarabine and Idarubicin vs Clofarabine plus Idarubicin and Ara-C in Patients with First Relapse or First Salvage of Primary Refractory acute myeloid leukemia (AML); and High-Grade Myelodysplastic Syndrome (MDS) (>/= 10% Blasts); or with Chronic Myeloid Leukemia (CML) in Myeloid Blasts Phase as Front Line Therapy or in First Salvage.

Physician

New Patient Referral



Name:	Stefan Faderl	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:	713-745-4613 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Outpatient visits at least weekly until CR, non-response, or resolution of toxicities. Return to MDACC thereafter every 3-6 months during the first year and then every 6-12 months as long as on study.

Treatment Agents:	ARA-C Clofarabine Idarubicin	Home Care:	As required.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Patients are required to stay in the Houston area for at least 4 weeks during course 1. Longer stay may be required as judged by the treating physician.

Description/
Intervention:

The goal of this clinical research study is to find the best safe dose for 2
different drug combinations. For this purpose, participants will either
receive the combination of clofarabine plus idarubicin or clofarabine plus
idarubicin and ara-C. Once the best safe dose for these drug combinations are
found, the next goal is to compare the drug combinations
clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in
the treatment of patients with AML, high-grade MDS, or myeloid blast phase of
CML who have relapsed following their initial therapy. In the current extension
part of the study, you will only receive the clofarabine/idarubicin/ara-C
combination. The activity and the safety of this treatment will be studied.

Study Objectives / Outcomes

1. To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of clofarabine plus idarubicin, and clofarabine plus idarubicin and ara-C.

2. To determine the complete response rate (CR and CRp) of clofarabine plus idarubicin and ara-C vs clofarabine and ara-C vs clofarabine and idarubicin. The primary efficacy endpoint will be success defined as the number of patients achieving CR/CRp.

3. To compare the toxicity profiles of clofarabine plus idarubicin and ara-C vs clofarabine and ara-C vs clofarabine and idarubicin.

4. To compare response duration (CR/CRp) and survival of clofarabine plus idarubicin and ara-C vs clofarabine and ara-C vs clofarabine and idarubicin.

Study Status Information



Study Activation / Registration Date:	09/08/2003

IRB Review and Approval Date:	04/16/2003

Study Type:	Therapeutic

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) Age >/= 18 years and < 60 years.

2) Must be in first relapse of AML, or must receive treatment as first salvage in primary refractory AML; or have high-risk MDS (>/= 10% blasts) with not more than one prior regimen of chemotherapy (therapy with hematopoietic growth factors, biological or targeted therapies are not counted). Patients in CML myeloid blast phase may receive clofarabine as frontline therapy or in first salvage.

3) Total bilirubin </= 2mg/dL, SGPT </= 4 ULN, creatinine </= 2.0mg/dL.

4) ECOG performance status </= 2.

5) Signed informed consent.

6) Male and female patients who are fertile agree to use an effective barrier method of birth control (ie, latex condom, diaphragm, cervical cap, etc) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 7 days of study enrollment (applies only if patient is of childbearing potential. Non-childbearing is defined as >= 1 year postmenopausal or surgically sterilized).

Exclusion Criteria:

1) Previous treatment with clofarabine.

2) Active, uncontrolled, systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment, or any severe, concurrent disease, which, in the judgment of the investigator and after discussion with the Principal Investigator, would make the patient inappropriate for study entry.

3) Symptomatic CNS involvement.

4) Patients who receive other chemotherapy. Patients must have been off previous therapy of >/= 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment. Treatment may start earlier following discussion with the Principal Investigator.

5) Cardiac ejection fraction </= 30%.

Links

Registration Number: NCT00067028
Study Information on Clinical Trials Registry (clinicaltrials.gov)