Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

Launched by M.D. ANDERSON CANCER CENTER · Apr 14, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating a combination of four chemotherapy drugs—cladribine, idarubicin, cytarabine, and venetoclax—to see how well they work in treating patients with certain types of blood cancers, specifically acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), and blastic phase chronic myeloid leukemia (CML). The goal is to determine if these medications can effectively stop the growth of cancer cells by either killing them or preventing them from multiplying.

To participate in the trial, patients should be 65 years old or younger and have a diagnosis of AML, acute biphenotypic leukemia, or high-risk MDS. Some patients with CML in the myeloid blast phase may also be eligible. Participants will need to meet specific health criteria, including having good liver and kidney function. Those who join the trial can expect to receive treatment and be monitored closely for their response to the medications. It’s important to note that pregnant or breastfeeding women cannot participate due to potential risks to the baby. If you think you might qualify or are interested in learning more, please discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 (1 or 4): 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 deemed able to receive venetoclax (ie. insurance clearance) will be assigned to Frontline cohort 4. 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 is required prior to their enrollment on the protocol.
• 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 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.