MDACC Study Summary 2007-0039

Study Summary
No. 2007-0039:.......Leukemia......Stefan Faderl......Leukemia

Study Summary Title



Study Summary Number:	2007-0039

Study Title:	Clofarabine plus Low-Dose Cytarabine Induction Followed by Consolidation of Clofarabine plus Low-Dose Cytarabine Alternating with Decitabine in Frontline AML and High-Risk MDS

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 II	Return Visit:	Prior to each course of therapy.

Treatment Agents:	Clofarabine Cytarabine Decitabine	Home Care:	Therapy will be administered at MDACC. Patients may receive further follow up at home (e.g. laboratory follow up evaluations, transfusions of blood products as and if needed, management of infectious complications etc.)

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Up to 5 weeks during induction. Patients will be admitted to the protective environment for this time.


Description/ Intervention:	The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.

Study Objectives / Outcomes

1. To assess disease-free (DFS) and overall survival (OS).

2. To assess complete remission (CR) rate.

3. To assess toxicity and induction mortality.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	05/06/2008

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) Previously untreated AML and high-risk MDS (>/= 10% blasts or >/= IPSS intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.

2) Age >/= 60 years.

3) ECOG performance status </= 2.

4) Adequate hepatic (serum total bilirubin </= 1.5 x ULN, SGPT and/or SGOT </= 2.5 x ULN) and renal function (creatinine </= 1.5 mg/dL).

5) Sign written informed consent

Exclusion Criteria:

1) Cardiac ejection fraction < 40%.

2) Prior therapy with clofarabine or decitabine.

3) Active and uncontrolled disease/infection as judged by the treating physician.

4) Pregnancy

5) Acute promyelocytic leukemia (APL).

6) Women of childbearing potential and men who do not practice contraception.

7) Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

Links

Registration Number: NCT00778375
Study Information on Clinical Trials Registry (clinicaltrials.gov)