Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04047641

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Led by M.D. Anderson Cancer Center · Updated on 2025-12-17

80

Participants Needed

1

Research Sites

427 weeks

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

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.

CONDITIONS

Official 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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of acute myeloid leukemia (≥ 20% blasts), acute biphenotypic leukemia, or high-risk myelodysplastic syndrome (> 10% bone marrow blasts)
  • Age 18 to 65 years for frontline patients
  • Age 18 years 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 patients have previously treated relapsed or refractory disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • 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
  • Normal potassium, magnesium, and calcium levels
  • Ability to take oral medication
  • Ability to understand and sign informed consent
  • Left ventricular ejection fraction of 50% or higher
  • 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
Not Eligible

You will not qualify if you...

  • Any medical condition that could interfere with study procedures or results
  • Breastfeeding women
  • Active malignancies or remission less than 6 months, except certain skin cancers
  • Active serious infections with fever ≥ 101°F within 48 hours before treatment
  • Significant gastrointestinal problems affecting drug absorption
  • Active central nervous system leukemia (history allowed if no active disease)
  • Known HIV infection or active viral hepatitis
  • Major surgery within 14 days before treatment
  • Heart problems including QTc interval ≥ 450 msec, congenital long QT syndrome, sustained ventricular tachycardia, significant ventricular fibrillation, second or third degree heart block (unless pacemaker present), heart rate under 50/min, certain bundle branch blocks, recent heart attack or unstable angina within 6 months, severe heart failure, recent atrial fibrillation, or family history of long QT syndrome
  • Taking strong CYP3A4 inducing medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Musa Yilmaz

CONTACT

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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