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Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase. | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

NCT06236724•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.

Detailed Description

Primary Objectives: • To assess the rate of major molecular response (MMR) by 12-months. Secondary Objectives: * To assess the rate of complete cytogenetic response (CCyR, or PCR ≤ 1% IS) by 12 months * To estimate the proportion of participants with 4.5-log reduction of BCR::ABL1 transcripts (MR4.5) at 6-, 12-,18-, 24-, and 36 months of therapy. * To estimate the rate of TFR * To estimate the time to progression, progression-free survival, and overall survival. * To assess the toxicity of this dosing schedule by evaluating the adverse events that occur while the participant is on asciminib therapy * To estimate the proportion of participants with sustained MR4.5 of 3 years and more. * To estimate the cumulative overall rate of MR4.5.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult participants age ≥18 years.
•Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase (i.e., time from diagnosis ≤12 months).
•Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for \<30 days are eligible.
•Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.
•ECOG performance status ≤2.
•Participants must have 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 or SGOT ≤3x ULN, creatinine clearance ≥30mL/min calculated using modified Cockcroft-Gault.
•Ability to understand and the willingness to sign a written informed consent document.
•The effects of asciminib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:
•* Postmenopausal (no menses in greater than or equal to 12 consecutive months).
•* History of hysterectomy or bilateral salpingo-oophorectomy.
+11 more criteria

Exclusion Criteria

•Participants who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.
•Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
•Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
•Participants who are receiving any other investigational agents.
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to asciminib or other agents used in study.
•NYHA cardiac class 3-4 heart disease
•* 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 QTc interval on pre-entry electrocardiogram (\> 460 msec)
+10 more criteria

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

January 31, 2024

Primary Completion Date

July 1, 2033

Completion Date

July 1, 2035

Last Updated

March 4, 2026

Enrollment

ESTIMATED participants

Conditions

Chronic Myeloid Leukemia

Interventions

Asciminib

DRUG

Contacts

Elias Jabbour, MD

CONTACT

(713) 792-4764 ejabbour@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

Inclusion Criteria

Exclusion Criteria

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