Asciminib maintenance after alloHCT or CAR T for adults with Ph+ ALL

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

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
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Academic / other)
• Drugs / interventions: CAR T, asciminib, chimeric antigen receptor
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT07250087 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Tampa, Florida

• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Rawan Faramand, MD — Moffitt Cancer Center
• Study coordinator: Valerie Trujillo

Conditions Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia