Actively Recruiting
A Combination of Cladribine, Idarubicin, Cytarabine, and Quizartinib for Treating Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome
Led by M.D. Anderson Cancer Center · Updated on 2025-12-17
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well the combination of cladribine, idarubicin, cytarabine, and quizartinib works and its side effects in treating adults with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). This includes patients newly diagnosed, those whose disease has returned, or those whose disease does not respond to treatment. The study aims to understand the treatment's safety, effectiveness, and the genetic factors that may influence patient response. Participants receive treatment in three phases: induction, consolidation, and maintenance. During induction, patients get idarubicin, cladribine, and cytarabine intravenously on specific days, and quizartinib by mouth daily on days 6 to 19, repeated up to two cycles every 28 days if no disease progression or serious side effects occur. Those responding to induction move to consolidation with similar drugs on adjusted days and quizartinib daily on days 4 to 28 for up to five cycles. Maintenance involves daily quizartinib by mouth for up to 12 cycles, repeated every 28 days. Throughout the study, participants will be regularly monitored for treatment effects and side effects for up to 12 months, including evaluations of survival and disease status. After completing study treatment, follow-up visits occur every 6 to 12 months to assess long-term outcomes. Researchers will also study genetic changes and specific cell populations linked to treatment response, helping to understand how the combination affects the disease over time.
CONDITIONS
Brief Title
Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML) with 20% or more blasts, acute biphenotypic leukemia, or high-risk myelodysplastic syndrome (MDS) with more than 10% bone marrow blasts
- Age 18 to 65 years for newly diagnosed patients; age 18 or older for relapsed patients
- Newly diagnosed patients must not have received chemotherapy except limited use of hydroxyurea, tretinoin, or low-dose cytarabine for brief control
- Relapsed or refractory patients with previously treated disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Creatinine level less than 1.5 mg/dL
- Total bilirubin less than 1.5 mg/dL unless due to hemolysis or congenital disorder
- Liver enzymes (SGPT) less than 2.5 times the upper limit of normal
- Potassium, magnesium, and calcium levels within normal limits
- Ability to take oral medication
- Ability to understand and provide signed informed consent
- Left ventricular ejection fraction at or above 50%
- Women of childbearing potential must have a negative pregnancy test within 7 days and use contraception during and for 30 days after treatment; men must agree to use condoms if partner is of childbearing potential
- Patients with isolated extramedullary myeloid neoplasm are eligible
You will not qualify if you...
- Any medical condition that may interfere with study procedures or results as judged by the treating physician
- Breastfeeding women
- Active malignancies or remission less than 6 months, except for certain skin cancers
- Active serious infections with fever above 101°F within 48 hours before starting treatment
- Significant gastrointestinal problems affecting quizartinib absorption
- Active central nervous system leukemia (patients with previous CNS leukemia but no active disease are allowed)
- Known HIV infection or active viral hepatitis
- Major surgery within 14 days before starting study drug
- Impaired heart function including abnormal ECG with QTc interval 450 milliseconds or more unless approved by medical monitor
- History of congenital long QT syndrome or certain serious heart arrhythmias
- Heart rate below 50 per minute on ECG
- Certain heart conduction blocks unless patient has a pacemaker
- Recent heart attack or unstable angina within 6 months
- Severe congestive heart failure (NY Heart Association class III or IV)
- Atrial fibrillation within 2 weeks before first dose
- Use of strong CYP3A4 inducing medications active at study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 2 cycles of 28 days each
Participants receive a combination of chemotherapy drugs including idarubicin, cladribine, cytarabine, and quizartinib to treat leukemia or high-risk myelodysplastic syndrome. This phase aims to induce remission.
Daily treatment during each 28-day cycle with intravenous infusions on specified days and oral medication daily on days 6-19
Duration - Up to 5 cycles of 28 days each
Participants who achieve remission continue treatment with the same combination of drugs to consolidate response and prevent relapse.
Daily treatment during each 28-day cycle with intravenous infusions on specified days and oral medication daily on days 4-28
Duration - Up to 12 cycles of 28 days each
Participants who maintain remission receive oral quizartinib daily to maintain response and prevent disease progression.
Daily oral medication during each 28-day cycle
Duration - Every 6 to 12 months after treatment ends
After treatment completion, participants are monitored regularly to assess their health and detect any disease recurrence.
Follow-up visits every 6 to 12 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Musa Yilmaz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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