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A Study of TKI Maintenance Therapy Following Allo-HSCT in Newly Diagnosed Ph+ Adult ALL

NCT05024357 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-10-01

No results posted yet for this study

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.

Conditions

  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia-Positive Acute Lymphoblastic Leukemia
  • ALL, Adult

Interventions

DRUG

Dasatinib

Take Dasatinib orally for 1 year or 6 months post-HSCT.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Pengcheng He · First Affiliated Hospital of Xian Jiaotong University

  • Xiaoning Wang · First Affiliated Hospital of Xian Jiaotong University

  • Huachao Zhu · First Affiliated Hospital of Xian Jiaotong University

  • Juan Ren · First Affiliated Hospital of Xian Jiaotong University

  • Ying Chen · First Affiliated Hospital of Xian Jiaotong University

  • Ting Fan · First Affiliated Hospital of Xian Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024357 on ClinicalTrials.gov