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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03331211
Enrollment
100
Registered
2017-11-06
Start date
2017-11-01
Completion date
2019-09-01
Last updated
2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoblastic, Acute

Keywords

Leukemia, Lymphoblastic, Acute

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.

Interventions

DRUGTKIs

Dasatinib combined with Chematherapy

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CMV and EBV reactivation rate2 yearsEvaluation of CMV and EBV reactivation after chemotherapy combined with TKIs therapy in ALL patients

Secondary

MeasureTime frameDescription
The number of large granulosa cells and T、B、NK cell activity2 yearsEvaluation of the relationship between the number of large granulosa cells and T、B、NK cell activity in patients with CMV positive after TKIs therapy

Countries

China

Contacts

Primary ContactXutao Guo
gxt827@126.com008613802426709

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026