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

NCT03331211 | Unknown

• 1 other identifier: NFH-ALL-CMV-2017
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Lymphoblastic, Acute

Keywords

Leukemia, Lymphoblastic, Acute

Outcome Measures

Primary Outcomes (1)

• CMV and EBV reactivation rate

  Evaluation of CMV and EBV reactivation after chemotherapy combined with TKIs therapy in ALL patients

  2 years

Secondary Outcomes (1)

• The number of large granulosa cells and T、B、NK cell activity

  2 years

Study Arms (1)

Chmotherapy combined with TKIs

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

Drug: TKIs

Interventions

TKIs DRUG

Dasatinib combined with Chematherapy

Also known as: Dasatinib, Nilotinib, Ponatinib, Imatinib

Chmotherapy combined with TKIs

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Department of Hematology,Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

Related 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 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.

  PMID: 27349810 RESULT

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Dasatinib; nilotinib; ponatinib; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Central Study Contacts

Xutao Guo

CONTACT

008613802426709; gxt827@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: November 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)