beta
Trial Radar AI
Clinical Trial NCT07493408 (ASIM-POST Ph+) for 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 is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

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+) Phase 2 45 First-in-Class Randomized Overall Survival

Not yet recruiting
Clinical Trial NCT07493408 (ASIM-POST Ph+) is designed to study Treatment for 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. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on March 30, 2026 until the study accrues 45 participants. Led by The University of Hong Kong, this study is expected to complete by December 31, 2037. The latest data from ClinicalTrials.gov was last updated on March 25, 2026.
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 a...

Show More
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 (...Show More
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)

Conditions
Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)Blastic Transformation of Chronic Myeloid LeukemiaPhiladelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL)Haematopoietic Stem Cell Transplant, Allogeneic
Other Study IDs
  • ASIM-POST Ph+
  • ASCPT-01
NCT ID Number
NCT07493408
Start Date (Actual)
2026-03-30
Last Update Posted
2026-03-25
Completion Date (Estimated)
2037-12-31
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Ph+ B-ALL
CML-BP
Asciminib
Asciminib add-on
allogeneic HSCT maintenance
Asciminib with Imatinib
Asciminib with Nilotinib
Asciminib with Dasatinib
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalStudy 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.
Asciminib add-on
Asciminib 80mg QD (in combination with Nilotinib or Dasatinib) or Asciminib 60mg QD (in combination with Imatinib)
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
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
Nilotinib
Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment
OtherControl Arm (TKIs only)
2-years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib
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
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
Nilotinib
Nilotinib 200mg BID (Ramp-up from 200mg QD for first 4-weeks then 200mg BID for subsequent weeks), Maximum 2-years treatment
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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).
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)
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
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.
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.
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.
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).
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.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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
The University of Hong Kong logoThe University of Hong Kong335 active studies to explore
Study Responsible Party
Professor Yok-lam Kwong, Principal Investigator, Professor, The University of Hong Kong
Study Central Contact
Contact: Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK), +852 2255 3975, [email protected]
Contact: Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK), +852 2255 3975, [email protected]
1 Study Locations in 1 Countries
The University of Hong Kong, Hong Kong, Hong Kong
Rebecca W.M. CHUNG, Contact, +852 2255 4155, [email protected]
Yok-Lam Kwong, MBBS, MD, FRCP(UK), FRCPath(UK, Principal Investigator
Garret M.K. LEUNG, MBBS, MRCP(UK), FHKCP(HK), Sub-Investigator
Joycelyn P.Y. SIM, MBBS, MRCP(UK), FHKCP(HK), Sub-Investigator