NCT07493408Not yet recruitingPhase 2
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
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)
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 30 Mar 2026
- Primary completion date
- 31 Dec 2035
- Lead sponsor
- The University of Hong Kong
- Diseases
- Acute lymphoblastic leukaemia, Chronic myeloid leukaemia, Chronic lymphocytic leukaemia, Acute myeloid leukemia
- NCT number
- NCT07493408
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 30 Mar 2026 to the primary completion date, 31 Dec 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled hypertension
Lab values
- Corrected QT interval (QTc) \> 460 milliseconds for women or \> 450 milliseconds for men
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.