Asciminib for Philadelphia Chromosome Positive ALL
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
Recruiting
Phase 1Interventional Study
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Who this trial is looking for
This trial is looking for adults who have been treated for a type of blood cancer called Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia. Participants will take a study drug called asciminib to see how well it works and what the best dose is.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have been diagnosed with Philadelphia Chromosome Positive ALL
I am in morphologic remission with less than 5% marrow blasts
I have an ECOG performance status of 0-2
I have adequate organ function
You may not be able to join if
I have active relapsed disease with more than 5% blasts
I have grade II-IV acute GVHD that requires systemic steroids
I have significant organ dysfunction or an uncontrolled infection
I am pregnant or breastfeeding
I have received a prior investigational CAR T product
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Status
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 G…
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
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