Clinical trial · Interventional
A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in Ph+ Adult ALL
A Randomized Controlled Study of Dasatinib Combined With Reduced Intensive Consolidation Chemotherapy in Newly Diagosed Philadelphia Chromesome Positive Adult 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 intensive chemotherapy has markedly improved the outcomes of philadelpha-positive lymphoblastic leukemia (Ph+ ALL). However, a considerable proportion of patients failed to complete the intended chemotherapy and some even died early. The optimal balance between the intensity of chemotherapy and safety should be explored. In this study, Ph+ ALL patients who achieve complete remission (CR) after VP regimen (vincristine and prednisone) plus dasatinib as induction are enrolled and then the participants will receive different consolidation chemotherapy. Patients in the group A will continue to use VP regimen plus dasatinib, while the group B receives hyper-CVAD/methotrexate-cytarabine regimen plus dasatinib. The measurable residual disease (MRD), CR, adverse effects (AE), overall survival (OS) and disease free survival (DFS) will be observed to determine the proper consolidation chemotherapy regimen.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine | Drug | — | UNRESOLVED |
| dasatinib plus consolidation chemotherapy with vincristine and prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dasatinib, Vincristine and Prednisone
- description
- After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone.
- interventionNames
- Drug: dasatinib plus consolidation chemotherapy with vincristine and prednisone
- type
- EXPERIMENTAL
- label
- Dasatinib, Methotrexate and Cytarabine
- description
- After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine.
- interventionNames
- Drug: dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine
Primary outcomes (2)
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. * Accept consolidation chemotherapy. * 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. * Do not accept follow-up.
References
Publications (0)
Data not yet available