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

NCT05026229 | Unknown

• 1 other identifier: XJTU1AF-CRF-2020-002-2
• Study Type: interventional
• Target: 60
• 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 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

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

Keywords

Philadelphia-Positive; Adult Acute Lymphoblastic Leukemia; Tyrosine Kinase Inhibitor; Consolidation Chemotherapy

Outcome Measures

Primary Outcomes (2)

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

  MRD refers to 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 Participants 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 (3)

• disease-free survival (DFS), months

  From date of consolidation chemotherapy until disease progression, the end of follow-up or the date of death from any cause, whichever came first.

• overall survival (OS), months

  From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.

• adverse effects (AE)

  From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.

Study Arms (2)

Dasatinib, Vincristine and Prednisone

EXPERIMENTAL

After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone.

Drug: dasatinib plus consolidation chemotherapy with vincristine and prednisone

Dasatinib, Methotrexate and Cytarabine

EXPERIMENTAL

After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine.

Drug: dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine

Interventions

dasatinib plus consolidation chemotherapy with vincristine and prednisone DRUG

After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone.

Also known as: Dasatinib + VP Regimen

Dasatinib, Vincristine and Prednisone

dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine DRUG

After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine.

Also known as: Dasatinib + HyperB Regimen

Dasatinib, Methotrexate and Cytarabine

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.
• Accept consolidation chemotherapy.
• 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.
• 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; Consolidation Chemotherapy; Vincristine; Prednisone; VDA-P protocol; Methotrexate; Cytarabine

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; Drug Therapy; Therapeutics; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminopterin; Pterins; Pteridines; Cytidine; Pyrimidine Nucleosides; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

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 30, 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)