RECRUITING

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

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Conditions

Acute Myeloid LeukemiaBlasts 20 Percent or More of Bone Marrow Nucleated CellsHigh Risk Myelodysplastic SyndromeRecurrent Acute Biphenotypic LeukemiaRecurrent Acute Myeloid LeukemiaRecurrent High Risk Myelodysplastic SyndromeRefractory Acute Myeloid LeukemiaRefractory High Risk Myelodysplastic Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Combination of Cladribine, Idarubicin, Cytarabine (CLIA) and Quizartinib for the Treatment of Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS))

Quick Facts

Study Start:2019-10-22
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04047641

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of
  2. * AML (World Health Organization \[WHO\] classification definition of \>= 20% blasts, excluding Acute promyelocytic leukemia),
  3. * Acute biphenotypic leukemia or
  4. * High-risk MDS (\> 10% bone marrow blasts)
  5. * Frontline cohort: Patients aged 18 to 65 years
  6. * Relapse cohort: Patients aged \>=18 years old
  7. * Patients may be newly diagnosed (Frontline cohort) or with prior therapy (Relapsed cohort) as follows:
  8. * 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
  9. * For relapsed cohort: Patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia or high-risk MDS (\> 10% bone marrow blasts)
  10. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  11. * Creatinine \< 1.5 mg/dl
  12. * Total bilirubin \< 1.5 mg/dL, unless increase is due to hemolysis or congenital disorder
  13. * Transaminases (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x upper limit of normal (ULN)
  14. * Potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits
  15. * Ability to take oral medication
  16. * Ability to understand and provide signed informed consent
  17. * Baseline test of left ventricular ejection fraction \>= 50%
  18. * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days
  19. * 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
  20. * Patients with isolated extramedullary myeloid neoplasm will be eligible
  1. * Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results
  2. * Breastfeeding women
  3. * 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
  4. * 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)
  5. * Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib
  6. * Documented active central nervous system leukemia (patients with history of central nervous system \[CNS\] leukemia without active disease are allowed)
  7. * Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis
  8. * Patients who have had any major surgical procedure within 14 days of day 1
  9. * Impaired cardiac function including any of the following:
  10. * 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
  11. * Patients with congenital long QT syndrome
  12. * Sustained ventricular tachycardia requiring medical intervention
  13. * Any history of clinically significant ventricular fibrillation or torsades de pointes
  14. * Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)
  15. * Heart rate of \< 50/minute on pre-entry ECG
  16. * Left bundle branch block
  17. * Right bundle branch block + left anterior hemiblock (bifascicular block)
  18. * Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug
  19. * Congestive heart failure (CHF) New York (NY) Heart Association class III or IV
  20. * Atrial fibrillation documented within 2 weeks prior to first dose of study drug
  21. * Known family history of congenital long QT syndrome
  22. * Patients who are actively taking a strong CYP3A4 inducing medication

Contacts and Locations

Study Contact

Musa Yilmaz
CONTACT
713-794-5783
myilmaz@mdanderson.org

Principal Investigator

Musa Yilmaz
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Musa Yilmaz, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-22
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-10-22
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Blasts 20 Percent or More of Bone Marrow Nucleated Cells
  • High Risk Myelodysplastic Syndrome
  • Recurrent Acute Biphenotypic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent High Risk Myelodysplastic Syndrome
  • Refractory Acute Myeloid Leukemia
  • Refractory High Risk Myelodysplastic Syndrome