Clinical trial · Interventional
Prophylactic HQP1351 Therapy Post-transplants on Leukemia After Allo-HSCT
Effect of Prophylactic HQP1351 Maintenance Post-transplants on Ph+ Luekemia Undergoing Allo-HSCT With MRD Positive Pre-transplants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Drugs was too expensive eligible for inclusion
Summary
Brief summary (as posted)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves the long-term outcomes for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and BC-CML. Relapse remains a major cause of treatment failure even after allo-HSCT. The prevention of relapse is essential for improving the outcome of Ph+ ALL. Pre-emptive tyrosine kinase inhibitor (TKIs) administration based on minimal residual disease (MRD) and BCR-ABL mutation after allo-HSCT might reduce the incidence of relapses and improve survival for patients with Ph+ luekemia. In this study, we will evaluate the safety and efficacy of newly third TKI-HQP1351 therapy post-transplants on Ph+ leukemia after allo-HSCT with MRD positive pre-transplants.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prophylactic HQP1351 Therapy | — | UNRESOLVED | — |
| Third Generation TKI | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HQP1351( Olverembatinib dimesylate) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HQP1351 prophylactic therapy
- description
- HQP1351 prophylactic therapy after allo-hct on days 30 to 60
- interventionNames
- Drug: HQP1351( Olverembatinib dimesylate)
Primary outcomes (1)
- measure
- Disease Free Survival（DFS）
- timeFrame
- 2 years
- description
- The time from the date of transplantation to leukemia relapse
Secondary outcomes (3)
- measure
- Overall survival(OS)
- timeFrame
- 2 years
- description
- the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up the time from the date of transplantation to relapse or death or the last day of follow-up The time from the date of transplantation to death or the last day of follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age of 18-65 years 2. Ph+ luekemia(includ Ph+ALL and CML) undergoing allo-HSCT with MRD positive pre-transplants 3. Survival \> 30 days post-transplants 4. Laboratory parameters as defined below: Serum creatinine less than or equal to 2.0 x ULN AST and ALT less than or equal to 3 x ULN (less than or equal to 5 x ULN if unequivocal liver GvHD),Total bilirubin less than or equal to 3 x ULN 5. Ability to understand and willingness to sign a written informed consent form Exclusion Criteria: 1. Ph+ ALL undergoing allo-HSCT with MRD negative pre-transplants 2. Survival \<30 days post-transplants 3. MRD positive on day +30 post-transplants 4. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) 5. Patients with any conditions not suitable for the trial (investigators' decision)
References
Publications (0)
Data not yet available