RecruitingPhase 1 / Phase 2

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

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))

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and effects of three chemotherapy drugs—cladribine, idarubicin, and cytarabine—given with quizartinib. It is for adults with acute myeloid leukemia (AML) or certain other blood cancers that are newly diagnosed, have come back, or have not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have AML, mixed-type acute leukemia, or high-risk myelodysplastic syndrome (MDS), a bone marrow disease. Myeloid cancer found only outside the bone marrow is also allowed.
  • Be age 18–65 for the newly diagnosed group, or age 18 or older for the previously treated group.
  • For the newly diagnosed group, have had no chemotherapy for AML or MDS, with some exceptions for short-term treatment or prior MDS drugs. The previously treated group allows cancer that came back or did not respond.
  • Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
  • Meet the study’s kidney, liver, and blood mineral test limits. Your heart must pump out at least 50% of its blood with each beat.
  • Be able to take medicine by mouth and understand and sign the consent form.
  • If you can become pregnant, have a negative pregnancy test within 7 days and use birth control until 30 days after the last study drug dose.
  • Men must agree not to father a child and use condoms if their partner can become pregnant. Men known to make no sperm do not need birth control.

Who can't join

  • A health condition that the doctor thinks could affect the study, or breastfeeding.
  • Another active cancer, or cancer that has been in remission for less than 6 months. Some early cancers and non-melanoma skin cancers are allowed.
  • A serious, uncontrolled infection. After a recent infection, you must have no fever of 101°F or higher for at least 48 hours before the first dose.
  • Stomach or bowel problems that could keep your body from absorbing quizartinib.
  • Active leukemia in the brain or spinal cord, known HIV infection, or active viral hepatitis, a liver infection.
  • Major surgery within 14 days before starting treatment.
  • Certain heart rhythm, heartbeat signal, or severe heart failure problems; a heart attack or unstable chest pain within 6 months; or certain personal or family histories of heart rhythm problems. Some exceptions need review.
  • Taking a medicine that strongly speeds up the liver enzyme called CYP3A4, which helps break down drugs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study sites (1)

TX