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.
Key facts
- Who runs it
- The University of Hong Kong
- Where
- Hong Kong, Hong KongSee the site
- Trial code
- 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
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 45 people, planned
- Started
- 30 Mar 2026
- Expected to end
- 31 Dec 2037
- Type of study
- Interventional, 2 groups
- Treatments tested
- Asciminib add-on
- Imatinib
- Dasatinib
- Nilotinib
- Record updated
- 25 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Ph+ B-cell acute lymphoblastic leukemia or blastic transformed CML who have had a donor stem-cell transplant and had TKI treatment before it.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Ph+ B-ALL or blastic transformed CML, after allogeneic stem-cell transplant (allo-HSCT).
- Earlier treatment
- Must have had TKI therapy in induction/consolidation before the transplant. Must not refuse standard TKI maintenance after the transplant.
- Biomarker or test result
- Ph-positive disease. Blood counts needed: absolute neutrophil count of 1.0 × 109/L or more and platelet count of 50 × 109/L or more.
Main reasons for not taking part
- Known atypical transcript that cannot be measured by available PCR methods
- Documented T315I mutation
- Taking ponatinib as the TKI
- ECOG performance status 2 or higher
- Uncontrolled hypertension
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Hong Kong
- The University of Hong KongHong Kong, Hong KongContact: Rebecca W.M. CHUNGNo longer taking part
About the trial
What the trial wants to find out
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
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
The 2 groups in the trial
- Study Arm (ASC + TKIs)Treatment being tested
Asciminib (ASC) add-on with a 2 years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib. TKI will be added from 5th week onwards after.
Treatment: Asciminib add-on, Imatinib, Dasatinib, and Nilotinib
- Control Arm (TKIs only)Other group
2-years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib
Treatment: Imatinib, Dasatinib, and Nilotinib
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Asciminib added to maintenance after stem cell transplant for Philadelphia chromosome-positive leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 25 March 2026