Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
- Conditions
- Chronic Myeloid Leukemia
- Registration Number
- NCT06236724
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:<br><br> - Adult participants age =18 years.<br><br> - Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early<br> chronic phase (i.e., time from diagnosis =12 months).<br><br> - Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an<br> FDA approved TKI for <30 days are eligible.<br><br> - Participants with additional chromosomal abnormalities at diagnosis (early disease)<br> and no other criteria for accelerated phase will be eligible for this study.<br><br> - ECOG performance status =2.<br><br> - Participants must have adequate end organ function, defined as the following: total<br> bilirubin =1.5x ULN (unless secondary to Gilbert's disease, in which case should be<br> =2.5x ULN), SGPT or SGOT =3x ULN, creatinine clearance =30mL/min calculated using<br> modified Cockcroft-Gault.<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document.<br><br> - The effects of asciminib on the developing human fetus are unknown. For this reason,<br> women of childbearing potential and men must agree to use adequate contraception<br> (hormonal or barrier method of birth control; abstinence) prior to study entry and<br> for the duration of study participation. (Refer to Pregnancy Assessment Policy MD<br> Anderson Institutional Policy # CLN1114). This includes all female patients, between<br> the onset of menses (as early as 8 years of age) and 55 years unless the participant<br> presents with an applicable exclusionary factor which may be one of the following:<br><br> - Postmenopausal (no menses in greater than or equal to 12 consecutive months).<br><br> - History of hysterectomy or bilateral salpingo-oophorectomy.<br><br> - Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal<br> range, who have received Whole Pelvic Radiation Therapy).<br><br> - History of bilateral tubal ligation or another surgical sterilization<br> procedure.<br><br> - Approved methods of birth control are as follows: Hormonal contraception (i.e. birth<br> control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine<br> device (IUD), Tubal Ligation or hysterectomy, Participants/Partner post vasectomy,<br> Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging<br> in sexual activity for the total duration of the trial and the drug washout period<br> is an acceptable practice; however periodic abstinence, the rhythm method, and the<br> withdrawal method are not acceptable methods of birth control. Should a woman become<br> pregnant or suspect she is pregnant while she or her partner is participating in<br> this study, she should inform her treating physician immediately.<br><br> - Men treated or enrolled on this protocol must also agree to use adequate<br> contraception prior to the study, for the duration of study participation, and 4<br> months after completion of asciminib administration.<br><br> - For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV<br> viral load must be undetectable on suppressive therapy, if indicated.<br><br> - Participants with a history of hepatitis C virus (HCV) infection must have been<br> treated and cured. For participants with HCV infection who are currently on<br> treatment, they are eligible if they have an undetectable HCV viral load.<br><br> - Participants with treated brain metastases are eligible if follow-up brain imaging<br> after central nervous system (CNS)-directed therapy shows no evidence of<br> progression.<br><br> - Participants with a prior or concurrent malignancy whose natural history or<br> treatment does not have the potential to interfere with the safety or efficacy<br> assessment of the investigational regimen are eligible for this trial.<br><br> - Participants with known history or current symptoms of cardiac disease, or history<br> of treatment with cardiotoxic agents, should have a clinical risk assessment of<br> cardiac function using the New York Heart Association Functional Classification. To<br> be eligible for this trial, participants should be class 2B or better.<br><br>Exclusion Criteria:<br><br> - Participants who have received more than 30 days of prior FDA approved TKI or more<br> than 2 doses of cytarabine.<br><br> - Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or<br> mitomycin C) prior to entering the study.<br><br> - Participants who have not recovered from adverse events due to prior anti-cancer<br> therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.<br><br> - Participants who are receiving any other investigational agents.<br><br> - History of allergic reactions attributed to compounds of similar chemical or<br> biologic composition to asciminib or other agents used in study.<br><br> - NYHA cardiac class 3-4 heart disease<br><br> - Cardiac Symptoms: Participants meeting the following criteria are not eligible<br> unless cleared by Cardiology:<br><br> - Uncontrolled angina within 3 months<br><br> - Diagnosed or suspected congenital long QT syndrome<br><br> - Any history of clinically significant ventricular arrhythmias (such as<br> ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).<br><br> - Prolonged QTc interval on pre-entry electrocardiogram (> 460 msec)<br><br> - History of significant bleeding disorder unrelated to cancer, including unless<br> cleared by hematologist or hemato-oncologist:<br><br> - Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)<br><br> - Diagnosed acquired bleeding disorder within one year (e.g., acquired<br> anti-factor VIII antibodies)<br><br> - Participants with active, uncontrolled psychiatric disorders including psychosis,<br> major depression, and bipolar disorders.<br><br> - Participants with cognitive impairment or psychiatric illness/social situations that<br> would limit compliance with study requirements.<br><br> - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral<br> therapy with undetectable viral load within 6 months are eligible for this trial.<br><br> - Evidence of other clinically significant uncontrolled condition(s) including, but<br> not limited to:<br><br> - Uncontrolled and/or active systemic infection (viral, bacterial or fungal)<br><br> - Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment and<br> having detectable virus load. Note: participants with serologic evidence of<br> prior vaccination to HBV (i.e. hepatitis B surface antigen negative, anti-HBs<br> antibody positive and anti-hepatitis B core antibody negative) or positive<br> anti-HBc antibody from intravenous immunoglobulins may participate.<br><br> - Pregnant women are excluded from this study because asciminib is a BCR::ABL1 TKI<br> with the potential for teratogenic or abortifacient effects. Because there is an<br> unknown but potential risk for adverse events in nursing infants secondary to<br> treatment of the mother with asciminib, breastfeeding should be discontinued if the<br> mother is treated with asciminib. These potential risks may also apply to other<br> agents used in this study.<br><br> - Participants in late chronic phase (i.e., time from diagnosis to treatment >12<br> months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are<br> excluded. The definitions
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and adverse events (AEs)
- Secondary Outcome Measures
Name Time Method