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New treatment option for Chronic Phase Chronic Myelogenous Leukemia
Official title ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase
ClinicalTrials.gov ID: NCT05007873
What this study is testing
What is Dasatinib?
Dasatinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for chronic phase chronic myelogenous leukemia.
Also referred to as BMS-354825, Dasatinib Hydrate.
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 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).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Diagnosis of Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis ≤12 months). Except...
- Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has historically been included as a...
- 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 \<...
- Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the...
You likely can't join if
- 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)
See the full eligibility 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...
- 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...
- 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...
- 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.
- 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: people with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface [HBs] antigen negative-, anti-HBs antibody positive...
- 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...
- 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
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 study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. 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.