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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

NCT07493408 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-25

No results posted yet for this study

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

Conditions

  • 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

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Yok-Lam KWONG, MBBS, MD, FRCP(UK), FRCPath(UK · The University of Hong Kong & Queen Mary Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2035-12-31
Completion
2037-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07493408 on ClinicalTrials.gov