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 | Not Yet Recruiting Phase 2

• 1 other identifier: ASCPT-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ph+ B-ALL; CML-BP; Asciminib; Asciminib add-on; allogeneic HSCT maintenance; Asciminib with Imatinib; Asciminib with Nilotinib; Asciminib with Dasatinib

Outcome Measures

Primary Outcomes (1)

• Morphological relapse-free survival (M-RFS)

  Morphological relapse-free survival (M-RFS) is defined as the time from date of allogeneic Hematopoietic Stem Cell Transplantation (HSCT) until the date of first documented morphological relapse or death from any cause, whichever occurs earlier. Morphological relapse is defined as the presence of ≥ 5% blasts in the bone marrow and/or evidence of new onset extramedullary disease.

  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.

Secondary Outcomes (7)

• Molecular relapse-free survival (m-RFS)

  From date of randomization until the date of first documented molecular relapse or death from any cause, whichever occurs earlier, up to 12 years.

• Cumulative incidence of grade II-IV acute Graft versus Host Disease (acute GvHD)

  Within 100 day after allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

• Cumulative incidence of chronic Graft versus Host Disease (chronic GvHD)

  From enrollment through study completion, an average of 2 years

• Treatment toxicities and Adverse Events (AEs)

  From randomization through treatment completion, an average of 2 years

• Event-free survival (EFS)

  From date of allogeneic HSCT until the date of first documented morphological relapse, molecular relapse, onset of acute of chronic GvHD or death from any cause, whichever occurs earlier, up to 12 years.

Study Arms (2)

Study Arm (ASC + TKIs)

EXPERIMENTAL

Asciminib (ASC) add-on with a 2 years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib. TKI will be added from 5th week onwards after.

Drug: Asciminib add-on; Drug: Imatinib; Drug: Dasatinib; Drug: Nilotinib

Control Arm (TKIs only)

OTHER

2-years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib

Drug: Imatinib; Drug: Dasatinib; Drug: Nilotinib

Interventions

Asciminib add-on DRUG

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

Study Arm (ASC + TKIs)

Imatinib DRUG

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

Control Arm (TKIs only); Study Arm (ASC + TKIs)

Dasatinib DRUG

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

Control Arm (TKIs only); Study Arm (ASC + TKIs)

Nilotinib DRUG

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

Control Arm (TKIs only); Study Arm (ASC + TKIs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Novartis: collaborator
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Imatinib Mesylate; Dasatinib; nilotinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Yok-Lam KWONG, MBBS, MD, FRCP(UK), FRCPath(UK

  The University of Hong Kong & Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK)

CONTACT

+852 2255 3975; lmk381@ha.org.hk

Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK)

CONTACT

+852 2255 3975; simpyj@ha.org.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a two-arm, parallel group, single-center, prospective, open-label, randomized clinical study to investigate the efficacy and safety of adding asciminib to the standard-of-care for post allogenic hematopoietic stem-cell transplant (HSCT) maintenance in patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (myeloid or lymphoid) (CML-BP) to prevent post-HSCT relapse. Ph+ B-ALL and CML-BP patients will not be stratified. Subjects in study group will receive Asciminib plus standard of care (SOC) while those in control group will receive SOC. Eligible subjects will be randomized into study group and control group in a 2:1 ratio.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: March 25, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2037
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

HK (1)