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 (ASIM-POST Ph+)

March 20, 2026 updated by: Professor Yok-lam Kwong, The University of Hong Kong

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (myeloid or lymphoid) (CML-BP) represent a group of high-risk disease. The outcome has improved since the introduction of tyrosine kinase inhibitors (TKIs). However, a significant proportion of patients still relapse despite undergoing allogeneic (allo-) hematopoietic stem cell transplant (HSCT) and post-transplant maintenance with TKIs. Moreover, many patients may not be able to tolerate the standard recommended dose of TKIs due to cytopenia especially during the early phase after transplant.

Asciminib is a first in class allosteric inhibitor that works by a mechanism totally different from the current TKIs in market. Its safety and efficacy have been studied in previous studies. We therefore postulate that combination of standard ATP-competitive TKIs (our current standard of care) and asciminib as post allo-HSCT maintenance can more effectively reduce risk of relapse post-transplant without increased toxicities.

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 HSCT maintenance in patients with Ph+ B-ALL or CML-BP to prevent post-HSCT relapse.

Subjects in study group will receive Asciminib plus standard of care (SOC) while those in control group will receive standard of care. Eligible subjects will be randomized into study group and control group in a 2:1 ratio.

The subjects in study group commence study drug (Asciminib) for post-transplant maintenance at 80 mg QD (in combination with nilotinib or dasatinib) or 60 mg QD (in combination with imatinib) after stable count recovery (i.e. absolute neutrophile count [ANC] ≥ 1.0 × 109/L, granulocyte colony-stimulating factor (G-CSF) independent and platelet ≥ 50 × 109/L, transfusion independent). SOC TKI will be added from 5th week onwards after.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK)
  • Phone Number: +852 2255 3975
  • Email: lmk381@ha.org.hk

Study Contact Backup

  • Name: Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK)
  • Phone Number: +852 2255 3975
  • Email: simpyj@ha.org.hk

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong
        • Contact:
        • Principal Investigator:
          • Yok-Lam Kwong, MBBS, MD, FRCP(UK), FRCPath(UK
        • Sub-Investigator:
          • Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK)
        • Sub-Investigator:
          • Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Age ≥ 18 years
  3. Patients with Ph+ B-ALL or CML-BP, who had undergone allogeneic HSCT
  4. Patients must have received TKI therapy in induction/consolidation therapy
  5. Absolute neutrophil count ≥ 1.0 × 109/L
  6. Platelet count ≥ 50 × 109/L

Exclusion Criteria:

  1. Patients with known atypical transcript that cannot be measured by available polymerase chain reaction (PCR) methods.
  2. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
  3. Uncontrolled hypertension
  4. Corrected QT interval (QTc) > 460 milliseconds for women or > 450 milliseconds for men
  5. Amylase and lipase values > 3 × upper limit of normal
  6. Patients refused standard TKI maintenance post-HSCT
  7. Unable to comply with study requirements
  8. Patients taking ponatinib as choice of TKI
  9. Patients with documented T315I mutation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Arm (ASC + TKIs)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphological relapse-free survival (M-RFS)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular relapse-free survival (m-RFS)
Time Frame: From date of randomization until the date of first documented molecular relapse or death from any cause, whichever occurs earlier, up to 12 years.
Molecular RFS is defined as the time from the date of randomization to the date of documented molecular relapse or the date of death from any causes, whichever occurs earlier. Molecular relapse was defined as loss of major molecular response (MMR, defined as BCR::ABL1 transcript ≤0.1% on the international scale for p210 transcript and/or a 3-log reduction from baseline for p190 transcript).
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)
Time Frame: Within 100 day after allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Cumulative incidence of grade II-IV acute GvHD (by Mount Sinai Acute GvHD International Consortium [MAGIC] criteria)
Within 100 day after allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Cumulative incidence of chronic Graft versus Host Disease (chronic GvHD)
Time Frame: From enrollment through study completion, an average of 2 years
Cumulative incidence of moderate to severe chronic GvHD (by National Institute of Health [NIH] criteria) requiring systemic treatment
From enrollment through study completion, an average of 2 years
Treatment toxicities and Adverse Events (AEs)
Time Frame: From randomization through treatment completion, an average of 2 years
Number of incidence of Treatment toxicities and adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 throughout the study duration, from baseline through 24 months post-treatment or end of study participation.
From randomization through treatment completion, an average of 2 years
Event-free survival (EFS)
Time Frame: 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.
Event-free survival (EFS) is defined as the time from the date of Hematopoietic Stem Cell Transplantation (HSCT) to the date of morphological disease relapse, molecular relapse, onset of acute or chronic GvHD, or death from any cause.
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.
Overall survival (OS)
Time Frame: From date of allogeneic HSCT until the date of death from any cause or trial completion, whichever occurs earlier, up to 12 years.
Overall survival (OS) is defined as the time from the date of Hematopoietic Stem Cell Transplantation (HSCT) to the time of death.
From date of allogeneic HSCT until the date of death from any cause or trial completion, whichever occurs earlier, up to 12 years.
2-year morphological relapse-free survival rate (2-year M-RFS rate)
Time Frame: From date of allogeneic HSCT until the date of first documented morphological relapse, molecular relapse, or death from any cause, whichever occurs earlier, up to 2 years.
The proportion of subjects with morphological relapse-free survival at 2 years from time of Hematopoietic Stem Cell Transplantation (HSCT).
From date of allogeneic HSCT until the date of first documented morphological relapse, molecular relapse, or death from any cause, whichever occurs earlier, up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Novartis
Queen Mary Hospital, Hong Kong

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2037

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASCPT-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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