Malignant Solid TumorsPhase 2NCT06629584
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
A Phase 2 study testing Asciminib in people with Malignant Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumors
- What is being tested?
- Asciminib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of Ph-positive (by cytogenetics or FISH) or BCR-ABL-positive (by PCR) CML in chronic phase and have received one prior line of therapy with a TKI.
- History of treatment failure defined as either:
- 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
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- 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
- ECOG performance status ≤ 2.
- 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
- 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.
Who cannot join
- Patients with a history of T315I mutation.
- Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF < 40% by echocardiogram or multi-gated acquisition (MUGA) scan.
- Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block).
- Corrected QT interval (QTc) of > 450 milliseconds (ms) on baseline electrocardiogram (ECG or EKG) (using the Fridericia Formula)
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
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- 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.
- Patients with known active infection with human immunodeficiency virus (HIV) or Hepatitis B or C.
- Patients with known conditions that would significantly affect the ingestion or gastrointestinal absorption of drugs administered orally.
- Nursing women, women of childbearing potential (WOCBP) with positive blood or urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (see inclusion criteria 8)
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
- ANC < 500/mm3, platelet count < 50,000 mm3.
- History of other active malignancy within 2 years prior to study entry except for previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.
- Subject has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
- Patients should have discontinued therapy with imatinib, bosutinib, dasatinib or nilotinib or other anti-leukemia therapy (except hydroxyurea), at least 48 hours prior to start of study therapy and recovered from any toxicity due to these therapies to at least grade 1. The use of hydroxyurea is allowed immediately prior to study entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Ghayas Issa, MD, 713-745-6798, gcissa@mdanderson.org
Ghayas Issa, MD
About this study
This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.
Read the detailed description
Primary Objectives:
- To determine the rate of major molecular response (MMR) at 12 months.
Secondary Objectives:
- To estimate the proportion of patients achieving a complete cytogenetic response (CCyR), major molecular response (MMR) and molecular response 4 and MR4.5 (MR4.5) by 3, 6, 12 (except for MMR as primary endpoint), 18 and 24 months.
- To estimate the time to CCyR, MMR, MR4.0 and MR4.5.
- To determine the safety and tolerability profile of asciminib in the second line setting.
- To determine the event-free survival (EFS), survival free from transformation to accelerated and blast phase (TFS), and overall survival (OS).
- To evaluate the rate of adverse events (AEs)
Exploratory Objectives:
- To describe patient reported outcomes using the MDASI-CML instrument
- To evaluate development of resistance mutations and their impact on outcomes
- Conditions
- Malignant Solid Tumors
- Being tested
- Asciminib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsciminibDrug
Patients will receive asciminib 80 mg PO once daily continuously for 28-day cycles for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Asciminib | Experimental | Patients will receive asciminib 80 mg once daily continuously for 28-day cycles for 2 years. Receives: Drug: Asciminib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major molecular response (MMR) rate by 12 months
MMR rate at 12 months with the 95% confidence interval will also be estimated.
Measured: at 12 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start14 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Ghayas Issa, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629584
- Sponsor's protocol ID
- 2024-0396
- Other IDs
- NCI-2024-07923
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06629584
- Acronym / sponsor ID
- 2024-0396
- Conditions
- Malignant Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.
Detailed description
Primary Objectives:
- To determine the rate of major molecular response (MMR) at 12 months.
Secondary Objectives:
- To estimate the proportion of patients achieving a complete cytogenetic response (CCyR), major molecular response (MMR) and molecular response 4 and MR4.5 (MR4.5) by 3, 6, 12 (except for MMR as primary endpoint), 18 and 24 months.
- To estimate the time to CCyR, MMR, MR4.0 and MR4.5.
- To determine the safety and tolerability profile of asciminib in the second line setting.
- To determine the event-free survival (EFS), survival free from transformation to accelerated and blast phase (TFS), and overall survival (OS).
- To evaluate the rate of adverse events (AEs)
Exploratory Objectives:
- To describe patient reported outcomes using the MDASI-CML instrument
- To evaluate development of resistance mutations and their impact on outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asciminib | Experimental | Drug: AsciminibPatients will receive asciminib 80 mg once daily continuously for 28-day cycles for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥ 18 years.
- Diagnosis of Ph-positive (by cytogenetics or FISH) or BCR-ABL-positive (by PCR) CML in chronic phase and have received one prior line of therapy with a TKI.
- History of treatment failure defined as either:
- ECOG performance status ≤ 2.
- 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:
Key exclusion criteria (15 listed)
- Patients with a history of T315I mutation.
- Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF < 40% by echocardiogram or multi-gated acquisition (MUGA) scan.
- Patients with a history of myocardial infarction within the last 6 months or unstable/uncontrolled angina pectoris or history of severe and/or uncontrolled ventricular arrhythmias. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block).
- Corrected QT interval (QTc) of > 450 milliseconds (ms) on baseline electrocardiogram (ECG or EKG) (using the Fridericia Formula)
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsciminibPatients will receive asciminib 80 mg PO once daily continuously for 28-day cycles for 2 years. | Drug | Asciminib |
Primary outcome
Major molecular response (MMR) rate by 12 months
Time frame: at 12 months of therapy
MMR rate at 12 months with the 95% confidence interval will also be estimated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ghayas Issa, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asciminib in people with Malignant Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghayas Issa, MD ((713) 745-6798, gcissa@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major molecular response (MMR) rate by 12 months (time frame: at 12 months of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.