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

September 29, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

A Randomized Controlled Study of Dasatinib Combined With Reduced Intensive Consolidation Chemotherapy in Newly Diagosed Philadelphia Chromesome Positive Adult Lymphoblastic Leukemia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

About 25% of adult patients with acute lymphoblastic leukemia (ALL) are associated with t (9; 22), positive philadelphia chromosome (Ph+ ALL), in whom BCR/ABL fusion gene can be detected in the bone marrow and peripheral blood. The use of tyrosine kinase inhibitors (TKI) plus intensive chemotherapy has markedly improved the outcomes of Ph+ ALL. However, it's reported that 74% pf patients failed to complete the intended chemotherapy, and early death occured in a considerable proportion of patients during induction. The optimal balance between the intensity of chemotherapy and safety need to be explored. In this study, Ph+ ALL patients are enrolled. The participants will receive dasatinib and induction chemotherapy using VP regimen (vincristine and prednisone) to achieve complete remission (CR). Then the participants will be randomly divided into two groups. The subjects inthe group A will continue to use VP regimen plus dasatinib as consolidation, while the patients in the group B receive 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pengcheng He
  • Phone Number: 0086-18991232609
  • Email: hepc@163.com

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xian Jiaotong University
        • Contact:
          • Pengcheng He
          • Phone Number: 0086-18991232609
          • Email: hepc@163.com
        • Contact:
        • Principal Investigator:
          • Xiaoning Wang
        • Principal Investigator:
          • Huachao Zhu
        • Principal Investigator:
          • Juan Ren
        • Principal Investigator:
          • Ying Chen
        • Principal Investigator:
          • Ting Fan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dasatinib, Vincristine and Prednisone
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
After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone.
Other Names:
  • Dasatinib + VP Regimen
Experimental: Dasatinib, Methotrexate and Cytarabine
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
After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine.
Other Names:
  • Dasatinib + HyperB Regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Measurable Residual Disease (MRD) Positivity
Time Frame: 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.
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)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival (DFS), months
Time Frame: From date of consolidation chemotherapy until disease progression, the end of follow-up or the date of death from any cause, whichever came first.
The measure of time after consolidation chemotherapy during which no sign of ALL is found.
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
Time Frame: From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.
The length of time from the date of diagnosis that Ph+ ALL patients are still alive.
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)
Time Frame: From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.
An adverse effect is any untoward medical occurrence in clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
From date of consolidation chemotherapy until the end of follow-up or the date of death from any cause, whichever came first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Chair: Pengcheng He, First Affiliated Hospital of Xian Jiaotong University
  • Study Director: Xiaoning Wang, First Affiliated Hospital of Xian Jiaotong University
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2021

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2020-002-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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