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New treatment option for Acute Myeloid Leukemia
Official title Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT04047641
What this study is testing
What is Cladribine?
Cladribine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as 2-CdA, 2CDA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Active clinically serious and uncontrolled infection. Patients with recent infections must have no temperature of \>= 101 degrees Fahrenheit (F) for...
- 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)
See the full eligibility 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...
- 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...
- Patients with isolated extramedullary myeloid neoplasm will be eligible
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.