Asciminib maintenance after alloHCT or CAR T for adults with Ph+ ALL
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
Run by H. Lee Moffitt Cancer Center and Research Institute · NCT07250087 · Data updated 2026-11-12
Doctors will try asciminib in adults with Ph+ ALL who are in remission after an allogeneic stem cell transplant or CAR T therapy to check safety and find the best dose to help prevent relapse.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | CAR T, asciminib, chimeric antigen receptor |
| Locations | 1 site (Tampa, Florida) |
| Status | Recruiting |
| Started | January 21, 2026 |
| Main results expected | November 2029 |
| Study ends | November 2029 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07250087 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) with Ph+ B-ALL in morphologic remission (<5% blasts) after alloHCT or CAR T, with ECOG 0–2 and adequate organ function.
✕Probably not a fit
Patients with active relapsed disease (>5% blasts), grade II–IV acute GVHD requiring systemic steroids, significant organ dysfunction, uncontrolled infection, or who are pregnant or breastfeeding are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 1, open-label study enrolls adults (≥18) with Philadelphia chromosome–positive B-cell acute lymphoblastic leukemia who are in morphologic remission after an allogeneic stem cell transplant (cohort A) or CAR T therapy (cohort B). Participants will receive asciminib and be monitored for safety, tolerability, and dose-limiting toxicities to establish the recommended dose for future studies. Key eligibility includes ECOG 0–2, adequate organ function, and <5% marrow blasts, while active relapse, significant GVHD on systemic steroids, uncontrolled infection, and pregnancy are exclusionary. The study is sponsored by H. Lee Moffitt Cancer Center with collaboration from Novartis and is conducted at Moffitt in Tampa, Florida.
Why it matters
Potential benefit: If successful, asciminib maintenance could reduce relapse risk and extend remission duration for adults with Ph+ ALL after transplant or CAR T therapy.
How similar studies have gone: Asciminib has shown strong activity and approval in chronic myeloid leukemia, but its use as post-transplant or post–CAR T maintenance in Ph+ ALL is largely untested and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Moffitt Cancer Center
Tampa, Florida, United States Recruiting
Study contacts
- Principal investigator: Rawan Faramand, MD — Moffitt Cancer Center
- Study coordinator: Valerie Trujillo
- Email: Valerie.Trujillo@moffitt.org
- Phone: 813-745-3178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.