Phase 2 Study of Asciminib for Chronic Myeloid Leukemia
This study is testing asciminib as a second-line treatment for chronic phase chronic myeloid leukemia (CML). CML is a type of cancer that affects the blood and bone marrow. You may be able to join if you are 18 or older, have CML that is Philadelphia chromosome (Ph)-positive or BCR-ABL-positive, and have already received one other treatment called a TKI. You must also have had treatment failure with your previous TKI. The main goal is to see how many participants achieve a major molecular response (MMR) within 12 months, which means a significant reduction in the amount of the cancer gene. This study plans to enroll 40 participants.
- Study design
- This is an open-label, single-arm Phase 2 study. It will enroll 40 participants to receive asciminib.
- What's involved
- Participants will take asciminib 80 mg by mouth once daily continuously for 28-day cycles for 2 years. Regular assessments will be done to check for treatment response and side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 12 months. Other responses are tracked up to 24 months.
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NCT06629584
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~40 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Asciminib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major molecular response (MMR) rate by 12 months
Measured over at 12 months of therapy
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Ghayas Issa, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
BCR::ABL1 \>0.1% for patients with intolerance to first-line TKI
Less than complete hematologic response (CHR) at ≥3 months
No partial cytogenetic response at ≥3 months
BCR::ABL1 ≥ 10% at if 3-6 months
BCR::ABL1 ≥ 1% at ≥6 months
Loss of CCyR or development of mutations or other clonal chromosomal abnormalities at any time during TKI treatment 4. ECOG performance status ≤ 2. 5. Adequate end organ function within 12 days before the first dose of asciminib treatment. Patients with mild to moderate renal and hepatic impairment are eligible if:
Total bilirubin ≤ 3.0 x ULN without AST/ALT increase
Aspartate transaminase (AST) ≤ 5.0 x ULN
Alanine transaminase (ALT) ≤ 5.0 x ULN
Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN and ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis
Alkaline phosphatase ≤ 2.5 x ULN
Creatinine clearance ≥ 30 mL/min as calculated using Cockcroft-Gault formula 6. The effects of Asciminib on the developing human fetus are unknown. For this reason, women of child-bearing 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. Women of child-bearing potential must agree to use highly effective methods of contraception during dosing and for 30 days after study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Allowable methods of birth control:
Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before the start of study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject.
Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
Sexually active males must use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Exclusion
Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointes that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication. 6. Patients with known active infection with human immunodeficiency virus (HIV) or Hepatitis B or C. 7. Patients with known conditions that would significantly affect the ingestion or gastrointestinal absorption of drugs administered orally.
What this trial measures
- Major molecular response (MMR) rate by 12 monthsat 12 months of therapy
MMR rate at 12 months with the 95% confidence interval will also be estimated.