Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukem… (NCT02115295) | Clinical Trial Compass
RecruitingPhase 2
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia
United States508 participantsStarted 2014-05-19
Plain-language summary
This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. For Salvage cohort: Patients with previously treated, relapsed or refractory AML, Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.
. Age \</= 65 years.
. Adequate organ function as defined below:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines four drugs — cladribine, idarubicin, cytarabine, and venetoclax — which is a more intensive regimen than some other options; can you walk me through what side effects or risks this combination might carry for someone in my specific situation?
2Since this is a Phase 2 trial, the main goal is to measure how many patients achieve a complete response rather than to definitively prove long-term survival benefit — does that change how you'd weigh this against standard treatment options available to me right now?
3My diagnosis falls into one of the categories this trial covers, but the trial includes everything from newly diagnosed AML to refractory or secondary cases; given where I am in my treatment history, do you think I'd be a good candidate, and would standard induction chemotherapy be a better first step?
4The trial is measuring complete response rate as its main outcome — if I did achieve a complete response on this regimen, what would the next step likely be, and does this trial path lead toward or away from a stem cell transplant if that might be relevant for me?
5This trial is still actively recruiting at this point — do you know which centers are running it, and is the travel or time commitment for this kind of intensive inpatient chemotherapy protocol realistic given my current health and support system?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
. 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
. 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.
. 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.
. Patient with documented hypersensitivity to any of the components of the chemotherapy program.
. 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.