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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

NCT ID: NCT03331211

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-09-01

Brief Summary

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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

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Conditions

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Leukemia, Lymphoblastic, Acute

Keywords

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Leukemia, Lymphoblastic, Acute

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Chmotherapy combined with TKIs

Patients with ALL were treated by chmotherapy and TKIs(PDT-NFH-2016)

TKIs

Intervention Type DRUG

Dasatinib combined with Chematherapy

Interventions

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TKIs

Dasatinib combined with Chematherapy

Intervention Type DRUG

Other Intervention Names

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Dasatinib Nilotinib Ponatinib Imatinib

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Qifa Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Hematology,Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xutao Guo

Role: CONTACT

Phone: 008613802426709

Email: [email protected]

Facility Contacts

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Xutao Guo

Role: primary

References

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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.

Reference Type RESULT
PMID: 27349810 (View on PubMed)

Other Identifiers

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NFH-ALL-CMV-2017

Identifier Type: -

Identifier Source: org_study_id