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NOT YET RECRUITING
NCT07493408
PHASE2

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-03-30

Completion Date

2037-12-31

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

DRUG

Asciminib add-on

Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)

DRUG

Imatinib

Imatinib 300mg QD (Ramp-up from 100mg QD for first 4-weeks, 200mg QD for following 4-weeks then 300mg QD for subsequent weeks), Maximum 2-years treatment

DRUG

Dasatinib

Dasatinib 50mg QD (Ramp-up from 20mg QD for first 4-weeks, 40mg QD for following 4-weeks then 50mg QD for subsequent weeks), Maximum 2-years treatment

DRUG

Nilotinib

Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment

Locations (1)

The University of Hong Kong

Hong Kong, Hong Kong