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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03331211

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphoblastic, Acute	Drug: TKIs

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	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: Dasatinib Nilotinib Ponatinib Imatinib

Arm

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:

Dasatinib

Nilotinib

Ponatinib

Imatinib

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
Age Limits:>or= 14 years old.

Exclusion Criteria:

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