Observation of the Effect of Chemotherapy Combined With Tyrosinase Inhibitor on the Reactivation of CMV and EBV in Patients With Acute Lymphoblastic Leukemia

November 7, 2017 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University
Philadelphia-chromosome-positive or partial ph-like acute lymphoblastic leukemia (ALL) preferred chemotherapy combined with tyrosine kinase inhibitors (TKIS) therapy. Recently we found that there were cytomegalovirus reactivation and even cytomegalovirus infection in three ALL patients treated with chemotherapy combined with TKIs. However, the cytomegalovirus risk after dasatinib use in patients with philadelphia-chromosome-positive ALL is still unknown. It is reported that dasatinib can be observed in the treatment of philadelphia-chromosome-positive leukemia patients with significant increase in large granular lymphocytes, the cytomegalovirus is often positive, and this part of the patient's prognosis is relatively good. Dasatinib can inhibit SRC and TEC kinase, and induce immune function inhibition,and in vitro experiments have confirmed that it inhibits the immune function of T cells and NK cells. In this study, we examined the potential association between cytomegalovirus AND EBV reactivation the treatment of chemotherapy combined with TKIs, and the numbers of large granular cells and NK cell activity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Department of hematology,Nanfang Hospital
        • Contact:

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with acute lymphoblastic leukemia who had not previously received chemotherapy (except for hormone preconditioning) or started with chemotherapy but not more than 3 days, and CMV and EBV quantitative negative.

Description

Inclusion Criteria:

  1. Patients diagnosed with acute lymphoblastic leukemia who had not previously received chemotherapy (except for hormone preconditioning) or started with chemotherapy but not more than 3 days, and CMV and EBV quantitative negative;
  2. Age Limits:>or= 14 years old.

Exclusion Criteria:

  1. Patients who had previously received chemotherapy and hematopoietic stem cell transplantation;
  2. Patients with CMV and EBV infection before treatment and not to turn yin;
  3. The researchers considered unsuitable patients.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chmotherapy combined with TKIs
Patients with ALL were treated by chmotherapy and TKIs(PDT-NFH-2016)
Drug: TKIs
Dasatinib combined with Chematherapy
Other Names:
  • Imatinib
  • Dasatinib
  • Nilotinib
  • Ponatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CMV and EBV reactivation rate
Time Frame: 2 years
Evaluation of CMV and EBV reactivation after chemotherapy combined with TKIs therapy in ALL patients
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of large granulosa cells and T、B、NK cell activity
Time Frame: 2 years
Evaluation of the relationship between the number of large granulosa cells and T、B、NK cell activity in patients with CMV positive after TKIs therapy
2 years

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2017

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFH-ALL-CMV-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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