MDACC Study Summary 2009-0570

Study Summary
No. 2009-0570:.......Leukemia......Gautam Borthakur......Leukemia

Study Summary Title



Study Summary Number:	2009-0570

Study Title:	A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients with Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes

Physician

New Patient Referral



Name:	Gautam Borthakur	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:	713-563-1586 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Eisai, Inc.

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Cytarabine Dexamethasone E7070 Idarubicin	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 E7070 given alone or in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the study drug/study drug combination will also be studied.

Study Objectives / Outcomes

Primary objective:

1. To assess the complete response (CR) and CR with incomplete platelet recovery (CRp) rates with combination therapy of E7070, idarubicin and cytarabine in patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (HRMDS), and

2. To determine the safety and toxicity profile of combination therapy with combination therapy of E7070, idarubicin and cytarabine in patients with relapsed or refractory AML or HRMDS.

Secondary objectives:
To determine the:
1. duration of response;
2. disease-free survival; and
3. overall survival

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/01/2013

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) All patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) [except acute promyelocytic leukemia], or high-risk myelodysplastic syndrome (HRMDS) (Int-2 high risk by IPSS or >10% blasts in marrow).

2) Patients must be 18 years or older.

3) Patients must have a performance status of 0-2 (Zubrod scale).

4) Patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dL and/or creatinine clearance > 40 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the Principal Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.

5) Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or SGPT less than or equal to 3X the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than or equal to 5 X ULN) due to organ infiltration by disease may be eligible after discussion with the PI, and appropriate dose adjustments will be considered.

6) Patients must have normal cardiac ejection fraction

7) QTc interval </= 480 msecs.

8) Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

9) Female patients must not be pregnant or lactating. Female patients of childbearing potential (including those <1 year post-menopausal) and male patients must agree to use contraception.

Exclusion Criteria:

1) Patients must not have untreated or uncontrolled life-threatening infection.

2) Patients must not have received chemotherapy and/or radiation therapy within 2 weeks. Hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease (for up to 2 weeks immediately prior to start of study drug).

3) Any other medical condition, including mental illness or substance abuse, deemed by the PI to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.

4) Patients must not have received an investigational anti-cancer drug within two weeks of E7070 administration.

Links

Registration Number: NCT01692197
Study Information on Clinical Trials Registry (clinicaltrials.gov)