Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Tra… (NCT07493408) | Clinical Trial Compass
Not 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
Hong Kong45 participantsStarted 2026-03-30
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Morphological relapse-free survival (M-RFS)
Timeframe: From date of allogeneic HSCT until the date of first documented morphological relapse or death from any cause, whichever occurs earlier, up to 12 years.