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
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.
Disease Group: Leukemia
Treatment Agent: Cladribine
Treatment Location: Only at MD Anderson
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.
IRB Review and Approval Date: 02/07/2012
Recruitment Status: Open
Projected Accrual: N/A
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.
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.