Asciminib added to maintenance after stem cell transplant for Philadelphia chromosome-positive leukemia
Tests asciminib with usual drugs after transplant in adults with Philadelphia chromosome-positive leukemia.
Plain-language title generated from the registry record
Registry title: Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML
Key facts
- Where
- Hong Kong, Hong KongSee the site
- Phase
- Phase 2
Where in Hong Kong
- The University of Hong KongHong Kong, Hong KongNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Hong Kong
- Trial code
- NCT07493408
- Record updated
- 25 March 2026
- Original description
The goal of this clinical trial is to learn if Asciminib, a first in class allosteric inhibitor, as a add-on maintenance therapy can provides benefits and further prevents relapse in post allogenic hematopoietic stem-cell transplant (HSCT) of patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (CML-BP).Read full original descriptionShow less
Efficacy and Safety of Adding Asciminib to the Standard-of-care for Post Allogenic Hematopoietic Stem-cell Transplant (HSCT) Maintenance in Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL) or Blastic Transformed CML (Myeloid or Lymphoid) (CML-BP)
The goal of this clinical trial is to learn if Asciminib, a first in class allosteric inhibitor, as a add-on maintenance therapy can provides benefits and further prevents relapse in post allogenic hematopoietic stem-cell transplant (HSCT) of patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (CML-BP).
The main questions it aims to answer are:
Would Ascminib add-on maintenance therapyimprove Morphological relapse-free survival rate? Would Ascminib add-on maintenance therapy improve Molecular relapse-free survival and Overall survival ? Any toxicity or intolerable events during Ascminib add-on maintenance therapy?
Researchers will compare Study arm (Ascminib plus tyrosine-kinase inhibitors [TKIs]) and Control arm (TKIs only) to see if Ascminib add-on maintenance therapy would provide better relapse-free survival (RFS) with optimal tolerability.
Participants will
* Enrolled and Randomized into either Study arm or Control arm * Take Ascminib plus selected TKI or selected TKI only according to schedule * Visit the clinic once every 2-4 weeks for checkups and tests * Record and Report any adverse event and graft-versus-host-disease (GvHD) development
Inclusion: The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an informed consent form (ICF) indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF; Age ≥ 18 years; Patients with Ph+ B-ALL or CML-BP, who had undergone allogeneic HSCT; Patients must have received TKI therapy in induction/consolidation therapy; Absolute neutrophil count ≥ 1.0 × 109/L; Platelet count ≥ 50 × 109/L.
Exclusion: Uncontrolled hypertension; Corrected QT interval (QTc) > 460 milliseconds for women or > 450 milliseconds for men; Patients with known atypical transcript that cannot be measured by available polymerase chain reaction (PCR) methods; Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2; Amylase and lipase values > 3 × upper limit of normal; Patients refused standard TKI maintenance post-HSCT; Unable to comply with study requirements; Patients taking ponatinib as choice of TKI; Patients with documented T315I mutation.