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Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL

ConditionPhiladelphia Chromosome Positive Acute Lymphoblastic Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities

Morphologic remission (<5% marrow blasts)

ECOG performance status 0-2

Disqualifiers

Active relapsed disease (>5% blasts)

Grade II-IV acute GVHD requiring systemic steroids

Significant organ dysfunction or uncontrolled infection

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Asciminib

    Drug

    Treatment will be administered on an outpatient basis.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Patients post-alloHCTExperimental treatment 1 intervention
Group B: Patients post-CAR T cell therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recommended Phase 2 Dose

The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.

Time frame
Up to 24 months

Secondary outcomes

1

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.

Time frame
Up to 24 Months
2

Overall survival (OS)

Overall survival (OS) is defined as the time from starting asciminib to the date of death.

Time frame
Up to 24 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Novartis

Collaborator

Source ClinicalTrials.gov
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