Clinical trial · Interventional
A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL
A Randomized Controlled Study of Tyrosine Kinase Inhibitor Maintenance Therapy Following Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed Philadelphia Chromesome Positive Adult Acute Lymphoblastic Leukemia
- 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)
This project is a key clinical research project approved by the Clinical Research Center of the First Affiliated Hospital of Xi 'an Jiaotong University.Tyrosine kinase inhibitors (TKI) combined with chemotherapy and subsequent allogeneic hematopoietic stem cell transplantation (allo-HSCT) are routinely used in patients with philadelpha-positive lymphoblastic leukemia (Ph+ALL). However, TKI maintenance therapy post-HSCT remains controversial. In this study, Ph+ALL patients are enrolled and given dasatinib combined with chemotherapy followed by allo-HSCT. Then patients in the group A continuing to use dasatinib for 1 year is compared with those in the group B receiving dasatinib for 6 months after HSCT. The measurable residual disease (MRD), complete remission (CR), overall survival (OS), disease free survival (DFS), non-relapse mortality (NRM) and the incidence of graft versus host disease (GVHD) will be observed to determine the optimal duration of TKI maintenance therapy post-HSCT.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL, Adult | Adult Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Philadelphia-Positive Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia with t(9;22)(q34.1;q11.2); BCR-ABL1 | ALIAS | 0.90 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dasatinib for 1 year
- description
- After the allo-HSCT treatment, the patients in this group will continue to take dasatinib orally for 1 year.
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- Dasatinib for 6 months
- description
- After the allo-HSCT treatment, the patients in this group will receive dasatinib for 6 months.
- interventionNames
- Drug: Dasatinib
Primary outcomes (2)
- measure
- Percentage of Patients with Measurable Residual Disease (MRD) Positivity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 18-65 years old, newly diagnosed as Ph+ALL. * Sign the informed consent. * Have appropriate allo-HSCT donors. * Accept allo-HSCT. * Accept follow-up. Exclusion Criteria: * Liver and kidney function impairment: serum transaminase \> 2 times of the upper limit of normal value, total bilirubin \> 1.5 times of the upper limit of normal value, serum inosine \> the upper limit of normal value (97 umol/L). * Active hepatitis B, hepatitis C or tuberculosis infection. * Can not tolerate the adverse effects of dasatinib. * Pregnancy. * Diagnosis of mental disorders. * Failed to reach molecular complete remission (MCR) after the early treatment. * Do not accept follow-up.
References
Publications (0)
Data not yet available