Clinical trial NCT03331211: Observation of the Effect of Chemotherapy Combined With Tyrosinase Inhibitor on the Reactivation of CMV and EBV in Patients With Acute Lymphoblastic Leukemia
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia, Lymphoblastic, Acute
Keywords: Leukemia, Lymphoblastic, Acute
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: CMV and EBV reactivation rate
timeFrame: 2 years
Secondary outcomes:
measure: The number of large granulosa cells and T、B、NK cell activity
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital
state: Guangdong
Study officials:
References:
citation: Ishiyama K, Kitawaki T, Sugimoto N, Sozu T, Anzai N, Okada M, Nohgawa M, Hatanaka K, Arima N, Ishikawa T, Tabata S, Onaka T, Oka S, Nakabo Y, Amakawa R, Matsui M, Moriguchi T, Takaori-Kondo A, Kadowaki N. Principal component analysis uncovers cytomegalovirus-associated NK cell activation in Ph+ leukemia patients treated with dasatinib. Leukemia. 2017 Jan;31(1):203-212. doi: 10.1038/leu.2016.174. Epub 2016 Jun 14.