OncoMatch/Clinical Trials/NCT04047641
Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Is NCT04047641 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Cladribine and Cytarabine for acute myeloid leukemia.
Treatment: Cladribine · Cytarabine · Idarubicin · Quizartinib — This phase I/II trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, 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. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Exception: 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; hypomethylating agents for prior MDS and transfusions, hematopoietic growth factors or vitamins, temporary prior measures such as apheresis or Hydrea are allowed
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
Lab requirements
Kidney function
Creatinine < 1.5 mg/dl
Liver function
Total bilirubin < 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder; Transaminases (SGPT) < 2.5 x ULN
Cardiac function
Baseline test of left ventricular ejection fraction >= 50%
Creatinine < 1.5 mg/dl; Total bilirubin < 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder; Transaminases (SGPT) < 2.5 x ULN; Baseline test of left ventricular ejection fraction >= 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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