MDACC Study Summary 2010-0736

Study Summary
No. 2010-0736:.......Leukemia......Hagop Kantarjian......Leukemia

Study Summary Title



Study Summary Number:	2010-0736

Study Title:	A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients with Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

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:	713-792-7026 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Cephalon, Inc.

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Cytarabine Omacetaxine Mepesuccinate	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.

Study Objectives / Outcomes

Phase IIa Portion
Evaluate toxicity of the schedule of OM for 3 days and Cytarabine for 7 days in 6 patients. Determine safety and Phase IIb schedule.

Phase IIb Portion
Evaluate efficacy of the combination in older patients with AML or high-risk MDS.
a. Primary endpoint: achievement of complete response (CR)
b. Secondary endpoints: evaluation of CR duration, disease-free survival, survival, regimen toxicity, and induction mortality.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	07/14/2011

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) Previously untreated AML (>/= 20% blasts). Patients with high-risk (intermediate-2 or high by IPSS or ≥10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. A single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.

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 </= 2.0 mg/dL).

5) Patients must be willing and able to review, understand, and provide written consent before starting therapy.

Exclusion Criteria:

1) NYHA class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), diabetes mellitus, or congestive heart failure.

2) Myocardial infarction in the previous 12 weeks (from the start of treatment).

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. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.

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: NCT01272245
Study Information on Clinical Trials Registry (clinicaltrials.gov)