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

Starting soon · Phase 2

Conditions studied: Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), Blastic Transformation of Chronic Myeloid Leukemia, Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL), Haematopoietic Stem Cell Transplant, Allogeneic

In brief

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

Key facts

Study ID

NCT07493408

Run by

The University of Hong Kong

People needed

45

Starts

2026-03-30

Expected to finish

2037-12-31

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with known atypical transcript that cannot be measured by available polymerase chain reaction (PCR) methods.
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
• Uncontrolled hypertension
• Corrected QT interval (QTc) > 460 milliseconds for women or > 450 milliseconds for men
• 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 it is running

• The University of Hong Kong — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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