MDACC Study Summary 2011-0987

Study Summary
No. 2011-0987:.......Leukemia......Tapan Kadia......Leukemia

Study Summary Title



Study Summary Number:	2011-0987

Study Title:	PHASE II STUDY OF CLADRIBINE PLUS LOW DOSE CYTARABINE (LDAC) INDUCTION FOLLOWED BY CONSOLIDATION WITH CLADRIBINE PLUS LDAC ALTERNATING WITH DECITABINE IN PATIENTS WITH UNTREATED AML OR HIGH-RISK MDS

Physician

New Patient Referral



Name:	Tapan Kadia	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:	713-563-3534 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Cladribine Cytarabine Decitabine	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 cladribine given in
combination with low-dose cytarabine (LDAC) and decitabine can help control the
disease in patients with AML or MDS. The safety of this drug combination will
also be studied.

Cladribine is designed to interfere with the cell's ability to process DNA (the
genetic material of cells). It can also insert itself into the DNA of cancer
cells to stop them from growing and repairing themselves.

Cytarabine is designed to insert itself into DNA of cancer cells to stop them
from growing and repairing themselves.

Decitabine is designed to damage the DNA of cells, which may cause cancer cells
to die.

Study Objectives / Outcomes

Primary objective:

To assess disease-free survival (DFS) of patients with acute myeloid leukemia (AML) treated with cladribine plus low-dose cytarabine (LDAC) alternating with decitabine.

Secondary objective

To assess overall survival (OS) of patients with AML treated with cladribine plus LDAC alternating with decitabine.
To assess the complete remission (CR) rate of patients with AML treated with cladribine plus LDAC alternating with decitabine.
To assess the overall response rate of patients with AML treated with cladribine plus LDAC alternating with decitabine.
To assess toxicity and induction mortality of patients with AML treated with cladribine plus LDAC alternating with decitabine.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	02/07/2012

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) Patients with previously untreated AML or high risk MDS (>/= 10 % blasts or IPSS >/= intermediate-2). Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or an isolated dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML.

2) Age >/= 60 years. Patients aged < 60 years who are unsuitable for standard induction therapy may be eligible after discussion with PI

3) Adequate organ function as defined below: liver function (bilirubin </= 2mg/dL, AST and/or ALT </=3 x ULN) kidney function (creatinine </= 1.5 x ULN ).

4) ECOG performance status of </= 2.

5) A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.

6) Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.

7) Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine.

Exclusion Criteria:

1) Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.

2) Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

3) Patient with documented hypersensitivity to any of the components of the chemotherapy program.

4) Men and women of childbearing potential who do not practice contraception. 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: NCT01515527
Study Information on Clinical Trials Registry (clinicaltrials.gov)