Cladribine, Idarubicin, Cytarabine, and Quizartinib for AML or High-Risk MDS
This study is looking at how well a combination of four drugs—cladribine, idarubicin, cytarabine, and quizartinib—works for people with newly diagnosed, relapsed (cancer has come back), or refractory (cancer hasn't responded to treatment) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). Cladribine, idarubicin, and cytarabine are chemotherapy drugs that stop cancer cells from growing. Quizartinib may also stop cancer growth by blocking enzymes. The study aims to see if combining these drugs helps control these conditions. We will measure how long people live without their disease getting worse (event-free survival) and track any side effects for up to 12 months. This study is for adults aged 18 and older with specific types of AML or high-risk MDS.
- Study design
- This is an interventional study with a planned enrollment of 80 participants. It is a Phase I/II trial, meaning it looks at both safety and effectiveness.
- What's involved
- Participants will receive idarubicin, cladribine, and cytarabine intravenously (into a vein), and quizartinib by mouth. Treatment cycles repeat every 28 days for up to 2 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for side effects and event-free survival for up to 12 months after starting treatment.
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NCT04047641
Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Recruiting
PHASE1Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~80 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:CladribineCytarabineIdarubicinQuizartinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event free survival (EFS)
Measured over From the date of start of treatment until event (resistance or relapse) or death, whichever occurred first, assessed up to 12 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Musa Yilmaz · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Diagnosis of
AML (World Health Organization \[WHO\] classification definition of \>= 20% blasts, excluding Acute promyelocytic leukemia),
Acute biphenotypic leukemia or
High-risk MDS (\> 10% bone marrow blasts)
Frontline cohort: Patients aged 18 to 65 years
Relapse cohort: Patients aged \>=18 years old
Patients may be newly diagnosed (Frontline cohort) or with prior therapy (Relapsed cohort) as follows:
For frontline cohort: Patients must be chemonaive, i.e., not have received any chemotherapy (except hydroxyurea \[Hydrea\] \[no dose limit\], tretinoin \[atra\] \[no dose limit\] or ara-C \[one or two doses (max 2 gr/m\^2 per dose)\] for transient control of hyperleukocytosis) for AML or MDS. They may have received hypomethylating agents for prior MDS and transfusions, hematopoietic growth factors or vitamins. Temporary prior measures such as apheresis or Hydrea are allowed
For relapsed cohort: Patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia or high-risk MDS (\> 10% bone marrow blasts)
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
Creatinine \< 1.5 mg/dl
Total bilirubin \< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder
Transaminases (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x upper limit of normal (ULN)
Potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits
Ability to take oral medication
Ability to understand and provide signed informed consent
Baseline test of left ventricular ejection fraction \>= 50%
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days
WOCBP must use appropriate method(s) of contraception such as oral contraceptive pills (OCP), birth control shots, intrauterine device (IUD) etc. WOCBP should use an adequate method to avoid pregnancy until 30 days after the last dose of investigational drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as men with known azoospermia do not require contraception
Patients with isolated extramedullary myeloid neoplasm will be eligible
Exclusion
Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results
Breastfeeding women
Patients with current active malignancies or any remission for \< 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may be in remission for less than 6 months or have active disease
Active clinically serious and uncontrolled infection. Patients with recent infections must have no temperature of \>= 101 degrees Fahrenheit (F) for at least 48 hours (hrs) (before first dose, day 1)
Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib
Documented active central nervous system leukemia (patients with history of central nervous system \[CNS\] leukemia without active disease are allowed)
Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis
Patients who have had any major surgical procedure within 14 days of day 1
Impaired cardiac function including any of the following:
Screening electrocardiography (ECG) with a corrected QT (QTc) \> 450 msec. The QTc interval will be calculated by Fridericia's correction factor (QTcF). The QTcF will be derived from the average QTcF in triplicate. Patients are excluded if they have QTcF \>= 450. Subjects with prolonged QTcF interval in the setting of RBBB (right bundle branch block) may participate upon review and approval by the medical monitor. RBBB for patients' triplicate electrocardiograms (EKGs) can show false QTc prolongation; therefore, the cardiology collaborator for this study will manually review to provide an accurate reading of the QTc
Patients with congenital long QT syndrome
Sustained ventricular tachycardia requiring medical intervention
Any history of clinically significant ventricular fibrillation or torsades de pointes
Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)
Heart rate of \< 50/minute on pre-entry ECG
Left bundle branch block
Right bundle branch block + left anterior hemiblock (bifascicular block)
Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug
Congestive heart failure (CHF) New York (NY) Heart Association class III or IV
Atrial fibrillation documented within 2 weeks prior to first dose of study drug
Known family history of congenital long QT syndrome
Patients who are actively taking a strong CYP3A4 inducing medication
What this trial measures
- Event free survival (EFS)From the date of start of treatment until event (resistance or relapse) or death, whichever occurred first, assessed up to 12 months
Will be estimate using the Kaplan-Meier method for each patient cohort. In addition, efficacy EFS will be analyzed in the intent to treat (ITT) population per cohort.
- Incidence of adverse eventsUp to 12 months
Defined as any clinically significant treatment-related grade 3 or greater non-hematologic toxicity. Patient toxicity data will be summarized using frequency and percentages, by type, grade and relationship to the study drugs.