Clinical trial · Interventional
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
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blastic Transformation of Chronic Myeloid Leukemia | — | UNRESOLVED | — |
| Haematopoietic Stem Cell Transplant, Allogeneic | — | UNRESOLVED | — |
| Ph+ Acute Lymphoblastic Leukemia (Ph+ALL) | — | UNRESOLVED | — |
| Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL) | — | UNRESOLVED | — |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Arm (ASC + TKIs)
- description
- 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.
- interventionNames
- Drug: Asciminib add-on
- Drug: Imatinib
- Drug: Dasatinib
- Drug: Nilotinib
- type
- OTHER
- label
- Control Arm (TKIs only)
- description
- 2-years treatment on ONE of the following tyrosine kinase inhibitors (TKIs): Imatinib / Dasatinib / Nilotinib
- interventionNames
- Drug: Imatinib
- Drug: Dasatinib
- Drug: Nilotinib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available