Philadelphia Chromosome Positive Acute Lymphoblastic LeukemiaPhase 1NCT07250087
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
A Phase 1 study testing Asciminib in people with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
- What is being tested?
- Asciminib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to Nov 2029
- Phase
- Phase 1
- 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+ B-ALL with detectable Philadelphia chromosome abnormalities
- Morphologic remission (<5% marrow blasts)
- ECOG performance status 0-2
- Adequate organ function
Who cannot join
- Active relapsed disease (>5% blasts)
- Grade II-IV acute GVHD requiring systemic steroids
- Significant organ dysfunction or uncontrolled infection
- Pregnancy or breastfeeding
- Prior investigational CAR T product
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
Moffitt Cancer Center
Tampa, Florida, 33612
Rawan Faramand, MD
Melissa Alsina, MD
About this study
Official title: Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome
Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). We're looking at two groups of adults:
one group had an Allogeneic Stem Cell Transplant (alloHCT) cohort A, and the other group had chimeric antigen receptor T cell (CAR T) therapy, cohort B. We also want to figure out what the best dose of asciminib is to use moving forward in future studies.
- Being tested
- Asciminib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsciminibDrug
Treatment will be administered on an outpatient basis.
| Study group | Role | What they receive |
|---|---|---|
| Patients post-alloHCT | Experimental | Individuals who have previously undergone an allogeneic stem cell transplant (alloHCT). Receives: Drug: Asciminib |
| Patients post-CAR T cell therapy | Experimental | Individuals who have received chimeric antigen receptor T cell therapy (CAR T). Receives: Drug: Asciminib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose
The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.
Measured: Up to 24 months
Secondary outcomes (2)
Relapse-free survival (RFS)
Relapse-free survival (RFS) is defined as the time from starting asciminib to the date of relapse or death, whichever comes first.
Measured: Up to 24 Months
Overall survival (OS)
Overall survival (OS) is defined as the time from starting asciminib to the date of death.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start21 Jan 2026
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome Positive Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Rawan Faramand, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250087
- Sponsor's protocol ID
- MCC-23477
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07250087
- Acronym / sponsor ID
- MCC-23477
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 26 Nov 2025 (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.
The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome
Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). We're looking at two groups of adults:
one group had an Allogeneic Stem Cell Transplant (alloHCT) cohort A, and the other group had chimeric antigen receptor T cell (CAR T) therapy, cohort B. We also want to figure out what the best dose of asciminib is to use moving forward in future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients post-alloHCT | Experimental | Drug: AsciminibIndividuals who have previously undergone an allogeneic stem cell transplant (alloHCT). |
| Patients post-CAR T cell therapy | Experimental | Drug: AsciminibIndividuals who have received chimeric antigen receptor T cell therapy (CAR T). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities
- Morphologic remission (<5% marrow blasts)
- ECOG performance status 0-2
- Adequate organ function
Key exclusion criteria (5 listed)
- Active relapsed disease (>5% blasts)
- Grade II-IV acute GVHD requiring systemic steroids
- Significant organ dysfunction or uncontrolled infection
- Pregnancy or breastfeeding
- Prior investigational CAR T product
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 |
|---|---|---|
| AsciminibTreatment will be administered on an outpatient basis. | Drug | Patients post-CAR T cell therapy, Patients post-alloHCT |
Primary outcome
Recommended Phase 2 Dose
Time frame: Up to 24 months
The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.
2 secondary outcomes
Relapse-free survival (RFS)
Time frame: Up to 24 Months
Overall survival (OS)
Time frame: Up to 24 Months
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 27 Mar 2026.
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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.
Rawan Faramand, MD principal investigator
Moffitt 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 1 study testing Asciminib in people with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia, run by H. Lee Moffitt Cancer Center and Research Institute 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 5 inclusion and 5 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 27 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Valerie Trujillo (813-745-3178, Valerie.Trujillo@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (time frame: Up to 24 months). 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 27 Mar 2026.