Asciminib for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, asciminib, to determine its safety for individuals previously treated for Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). The study focuses on two groups: those who have undergone an allogeneic stem cell transplant (a procedure replacing diseased bone marrow with healthy cells) and those who received CAR T cell therapy (a treatment using modified immune cells to fight cancer). Researchers aim to identify the safest and most effective dose of asciminib for future studies. Adults in remission with Ph+ B-ALL, having less than 5% cancer cells in their bone marrow, may be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how asciminib works in people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that asciminib is likely to be safe for humans?
Research has shown that asciminib is generally safe for individuals with certain blood cancers. In earlier studies, patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who took asciminib after other treatments tolerated it well. Studies have also shown that asciminib is safe for patients who haven't responded to or can't tolerate other treatments.
Another study found that combining asciminib with other drugs was safe for patients with this type of leukemia. Although this trial is in an early stage, current data suggest that asciminib is generally well-tolerated, with manageable and not too severe side effects for most people.12345Why do researchers think this study treatment might be promising for leukemia?
Unlike the standard treatments for acute lymphoblastic leukemia, which often include chemotherapy and targeted therapies, asciminib offers a novel approach. It uniquely targets the ABL myristoyl pocket (STAMP), which is different from how most existing treatments work. This specific targeting has the potential to be more selective and could reduce side effects often associated with broader-acting therapies. Researchers are excited about asciminib because it represents a new mechanism of action in the fight against this type of leukemia, potentially offering new hope for patients who have undergone allogeneic stem cell transplants or CAR T cell therapy.
What evidence suggests that asciminib might be an effective treatment for acute lymphoblastic leukemia?
Research has shown that asciminib may effectively treat Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL). In earlier studies, patients unresponsive to other treatments often achieved complete remission with asciminib. Another study found that asciminib significantly improved survival in animal tests. This drug targets specific genetic changes linked to the leukemia, potentially stopping cancer growth. In this trial, researchers are studying asciminib in patients who have already tried treatments like stem cell transplants or CAR T cell therapy, suggesting it could benefit these individuals.23678
Who Is on the Research Team?
Rawan Faramand, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with a blood cancer called Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL) who have already undergone either an Allogeneic Stem Cell Transplant (alloHCT, cohort A) or chimeric antigen receptor T cell (CAR T) therapy (cohort B).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive asciminib maintenance therapy following alloHCT or CAR T to prevent relapse
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Asciminib
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania