PHASE II STUDY OF CLADRIBINE PLUS IDARUBICIN PLUS CYTARABINE (ARAC) IN PATIENTS WITH AML, HR MDS, OR MYELOID BLAST PHASE OF CML
The goal of this clinical research study is to learn if the combination of cladribine, idarubicin, and cytarabine can help to control AML, high risk MDS, and/or CML in blast phase. The safety of these drugs will also be studied.
Disease Group: Leukemia,Malignant neoplasms stated as primary lymphoid haematopoietic
Treatment Agent: Cladribine,Cytarabine,Idarubicin
Treatment Location: Only at MDACC
Primary objective To determine the complete response rate (CR) of cladribine in combination with idarubicin and araC in patients with AML, High risk (HR) MDS, or myeloid blast phase of CML. Secondary objectives To determine the overall response rate (ORR) of cladribine in combination with idarubicin and araC in patients with AML, HR MDS, or myeloid blast phase of CML. To assess overall survival (OS) and event free survival (EFS) of patients treated with cladribine, idarubicin, and araC. To assess the duration of response to the combination in patients with AML, HR MDS, or myeloid blast phase of CML. To determine the safety and tolerability of the combination in patients with AML, HR MDS, or myeloid blast phase of CML. Exploratory objectives To study and describe the relationship between pretreatment patient / disease characteristics (including AML-associated molecular abnormalities) and outcome To identify molecular biomarkers predictive of response to therapy. To study and describe the relationship between patient / disease characteristics, use of intrathecal prophylaxis, and incidence of leptomeningeal disease.
IRB Review and Approval Date: 05/19/2014
Recruitment Status: Open
Projected Accrual: N/A
1) Patients with a diagnosis of AML, Acute Biphenotypic Leukemia, or
high risk MDS (>/= 10% blasts or IPSS >/= intermediate-2) will be
eligible. Patients with CML in Myeloid Blast Phase are also eligible.
2) For Frontline cohort: No prior potentially-curative therapy for leukemia. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed. Patients with secondary AMLwho have been treated for their antecedent myeloid neoplasm will be enrolled into the separate Secondary AML cohort.
3) For Salvage cohort: Patients with previously treated, relapsed or refractory AML, Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.
4) Age </= 65 years.
5) Adequate organ function as defined below: liver function (bilirubin </=2mg/dL, AST and/or ALT </=3 x ULN- or <5 x ULN if related to leukemic involvement), kidney function (creatinine </=1.5 x ULN ), known cardiac ejection fraction of > or = 45% within the past 6 months
6) ECOG performance status of </= 2.
7) A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
8) 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.
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 active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant 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.
Information and next steps
Leukemia,Malignant neoplasms stated as primary lymphoid haematopoietic
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