Is NCT04047641 recruiting in Houston, TX?

Yes, NCT04047641 is currently recruiting participants at its Houston, TX location. This acute myeloid leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute myeloid leukemia clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

About This Acute Myeloid Leukemia Study in Houston

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.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT04047641) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myeloid Leukemia Treatment Options in Houston, TX

If you're searching for acute myeloid leukemia treatment options in Houston, TX, this clinical trial (NCT04047641) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced acute myeloid leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myeloid leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Myeloid Leukemia Clinical Trial in Houston, TX

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