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

• Conditions: Leukemia, Lymphoblastic, Acute
• Interventions: Drug: TKIs

• Registration Number: NCT03331211
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-10-31
• Study Start: 2017-11-01
• Study First Posted: 2017-11-06
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chmotherapy combined with TKIs	TKIs	Patients with ALL were treated by chmotherapy and TKIs(PDT-NFH-2016)

Primary Outcome Measures

Name	Time	Method
CMV and EBV reactivation rate	2 years	Evaluation of CMV and EBV reactivation after chemotherapy combined with TKIs therapy in ALL patients

Secondary Outcome Measures

Name	Time	Method
The number of large granulosa cells and T、B、NK cell activity	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

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China