Is NCT05007873 recruiting in Houston, TX?

Yes, NCT05007873 is currently recruiting participants at its Houston, TX location. This chronic phase chronic myelogenous leukemia clinical trial is actively enrolling qualified participants.

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.

Chronic Phase Chronic Myelogenous Leukemia Clinical Trial in Houston, TX

Q: How do I join the chronic phase chronic myelogenous 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.

About This Chronic Phase Chronic Myelogenous Leukemia Study in Houston

This phase II trial studies the effect of ASTX727 and dasatinib in treating patients with newly diagnosed Philadelphia chromosome or BCR-ABL positive chronic myeloid leukemia in chronic phase. Philadelphia chromosome positive and BCR-ABL positive are types of genetic mutations (changes). Chemotherapy drugs, such as ASTX727, 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. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 and dasatinib may help to control Philadelphia chromosome-positive chronic myeloid leukemia or BCR-ABL positive chronic myeloid leukemia in chronic phase.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Diagnosis of Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis ≤12 months). Except for hydroxyurea and/or 1 to 2 doses of cytarabine patients must have received no or minimal prior therapy, defined as \< 1 month (30 days) of prior Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI)

Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.

Eastern Cooperative Oncology Group (ECOG) performance of 0-2

Adequate end organ function, defined as the following: total bilirubin \<1.5x ULN (unless secondary to Gilbert's disease, in which case should be \< 2.5x ULN), SGPT \<3x ULN, creatinine clearance ≥ 30mL/min calculated using modified Crokcroft-Gault.

Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment.

Exclusion Criteria

New York Heart Association (NYHA) cardiac class 3-4 heart disease

Cardiac Symptoms: Patients meeting the following criteria are not eligible unless cleared by Cardiology:

Uncontrolled angina within 3 months

Diagnosed or suspected congenital long QT syndrome

Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).

Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 460 msec)

History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist

Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)

Patients with active, uncontrolled psychiatric disorders include: psychosis, major depression, and bipolar disorders

Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required)

Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:

Uncontrolled and/or active systemic infection (viral, bacterial or fungal)

Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \[HBs\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \[HBc\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate

Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug. Pregnant or breast-feeding women are excluded. All WOCBP must have a negative pregnancy test prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive study drug and must not be enrolled in the study

Patients in late chronic phase (i.e., time from diagnosis to treatment \> 12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded. The definitions of CML phases are as follows:

Early chronic phase: time from diagnosis to therapy ≤ 12 months

Late chronic phase: time from diagnosis to therapy \> 12 months

Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow

Accelerated phase CML: presence of any of the following features:

Peripheral or marrow blasts 15% or more

Peripheral or marrow basophils 20% or more

Thrombocytopenia \< 100 x 10\^9/L unrelated to therapy

Documented extramedullary blastic disease outside liver or spleen

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 (NCT05007873) 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.

Chronic Phase Chronic Myelogenous Leukemia Treatment Options in Houston, TX

If you're searching for chronic phase chronic myelogenous leukemia treatment options in Houston, TX, this clinical trial (NCT05007873) 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 chronic phase chronic myelogenous 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 chronic phase chronic myelogenous leukemia clinical trials near you to find additional studies recruiting in your area.

Chronic Phase Chronic Myelogenous Leukemia Clinical Trial in Houston, TX

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