Overview

A Study of Dasatinib Plus Reduced Intensive Consolidation Chemotherapy in Ph+ Adult ALL

Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Treatments:
Cytarabine
Dasatinib
Methotrexate
Prednisone
Vincristine
Criteria
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.