Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Phase 2ASIM-POST Ph+NCT07493408
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
A Phase 2 study testing Asciminib add-on, Imatinib and Dasatinib in people with Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) and Blastic Transformation of Chronic Myeloid Leukemia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ph+ Acute Lymphoblastic Leukemia (Ph+ALL), Blastic Transformation of Chronic Myeloid Leukemia, Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL)
- What is being tested?
- Asciminib add-on, Imatinib and Dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Mar 2026to 31 Dec 2037
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Unable to comply with study requirements
- Patients taking ponatinib as choice of TKI
- Patients with documented T315I mutation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The University of Hong Kong
Hong Kong
Rebecca W.M. CHUNG, +852 2255 4155, rebeccachung@hku.hk
Yok-Lam Kwong, MBBS, MD, FRCP(UK), FRCPath(UK
About this study
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)
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:
Read more
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
Read the 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.
- 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
- Being tested
- Asciminib add-on, Imatinib, Dasatinib, Nilotinib
- Keywords
- Ph+ B-ALL, CML-BP, Asciminib, Asciminib add-on, allogeneic HSCT maintenance, Asciminib with Imatinib, Asciminib with Nilotinib, Asciminib with Dasatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asciminib add-onDrug
Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)
ImatinibDrug
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
DasatinibDrug
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
NilotinibDrug
Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Imatinib; Drug: Dasatinib; Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: 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)
Cumulative incidence of grade II-IV acute GvHD (by Mount Sinai Acute GvHD International Consortium [MAGIC] criteria)
Measured: Within 100 day after allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Cumulative incidence of chronic Graft versus Host Disease (chronic GvHD)
Cumulative incidence of moderate to severe chronic GvHD (by National Institute of Health [NIH] criteria) requiring systemic treatment
Measured: From enrollment through study completion, an average of 2 years
Treatment toxicities and Adverse Events (AEs)
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.
Measured: From randomization through treatment completion, an average of 2 years
Event-free survival (EFS)
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.
Measured: 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)
Overall survival (OS) is defined as the time from the date of Hematopoietic Stem Cell Transplantation (HSCT) to the time of death.
Measured: 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)
The proportion of subjects with morphological relapse-free survival at 2 years from time of Hematopoietic Stem Cell Transplantation (HSCT).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Professor Yok-lam Kwong, The University of Hong Kong
- Investigators
- Yok-Lam KWONG, MBBS, MD, FRCP(UK), FRCPath(UK, Principal investigator, The University of Hong Kong & Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493408
- Sponsor's protocol ID
- ASCPT-01
- Acronym
- ASIM-POST Ph+
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07493408
- Acronym / sponsor ID
- ASIM-POST Ph+ / ASCPT-01
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Novartis, Queen Mary Hospital, Hong Kong
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Arm (ASC + TKIs) | Experimental | Drug: Asciminib add-on, Drug: Imatinib, Drug: Dasatinib, Drug: NilotinibAsciminib (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. |
| Control Arm (TKIs only) | Other | Drug: Imatinib, Drug: Dasatinib, Drug: Nilotinib2-years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asciminib add-onAsciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib) | Drug | Study Arm (ASC + TKIs) |
| ImatinibImatinib 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 | Control Arm (TKIs only), Study Arm (ASC + TKIs) |
| DasatinibDasatinib 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 | Control Arm (TKIs only), Study Arm (ASC + TKIs) |
| NilotinibNilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment | Drug | Control Arm (TKIs only), Study Arm (ASC + TKIs) |
Primary outcome
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.
7 secondary outcomes
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.
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 chronic Graft versus Host Disease (chronic GvHD)
Time frame: 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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yok-Lam KWONG, MBBS, MD, FRCP(UK), FRCPath(UK principal investigator
The University of Hong Kong & Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asciminib add-on, Imatinib and Dasatinib in people with Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) and Blastic Transformation of Chronic Myeloid Leukemia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK) (+852 2255 3975, lmk381@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.