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

Leukemia, Lymphoblastic, Acute Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03331211
• Other study ID #: NFH-ALL-CMV-2017
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2017
• Last updated: November 7, 2017
• Start date: November 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xutao Guo
• Phone: 008613802426709
• Email: gxt827[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoblastic, Acute
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• TKIs
Dasatinib combined with Chematherapy

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 cytomegalovi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CMV and EBV reactivation rate	Evaluation of CMV and EBV reactivation after chemotherapy combined with TKIs therapy in ALL patients	2 years
Secondary	The number of large granulosa cells and T?B?NK cell activity	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