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

NCT05024357 | Unknown

• 1 other identifier: XJTU1AF-CRF-2020-002-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Philadelphia-Positive; Adult Acute Lymphoblastic Leukemia; Allogeneic Hematopoietic Stem Cell Transplantation; Tyrosine Kinase Inhibitors

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients with Measurable Residual Disease (MRD) Positivity

  MRD means the subclinical levels of residual leukemia.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

• Percentage of Patients with Complete Remission (CR)

  CR means that the blood counts have returned to normal, the leukemia cannot be seen when a bone marrow sample is examined under the microscope, and the signs and symptoms of the ALL are gone.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

Secondary Outcomes (5)

• Disease-free Survival (DFS), months

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

• Overall Survival (OS), months

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.

• Non-relapse Mortality (NRM), rate or percentage

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

• Incidence of graft versus host disease (GVHD), rate or percentage

  From date of randomization until the date of GVHD occurrence or date of death from any cause, whichever came first, assessed up to 36 months.

• Adverse Effects (AE)

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months.

Study Arms (2)

Dasatinib for 1 year

EXPERIMENTAL

After the allo-HSCT treatment, the patients in this group will continue to take dasatinib orally for 1 year.

Drug: Dasatinib

Dasatinib for 6 months

EXPERIMENTAL

After the allo-HSCT treatment, the patients in this group will receive dasatinib for 6 months.

Drug: Dasatinib

Interventions

Dasatinib DRUG

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

Also known as: Dasatinib tablet

Dasatinib for 1 year; Dasatinib for 6 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, newly diagnosed as Ph+ALL.
• Sign the informed consent.
• Have appropriate allo-HSCT donors.
• Accept allo-HSCT.
• Accept follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Pengcheng He

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

• Xiaoning Wang

  First Affiliated Hospital of Xian Jiaotong University

  STUDY DIRECTOR

• Huachao Zhu

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

• Juan Ren

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

• Ying Chen

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

• Ting Fan

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengcheng He

CONTACT

0086-18991232609; hepc@163.com

Xiaoyan Zheng

CONTACT

0086-15829370502; xiaoy_2008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 27, 2021
• Study Start: September 6, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 1, 2021

Record last verified: 2021-08

Locations

CN (1)