Overview

A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed 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 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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Treatments:
Dasatinib
Criteria
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.