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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

This study is currently recruiting participants.
Verified September 2017 by Qifa Liu, Nanfang Hospital of Southern Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03331211
First Posted: November 6, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University
  Purpose
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.

Condition Intervention
Leukemia, Lymphoblastic, Acute Drug: TKIs

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
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

Resource links provided by NLM:


Further study details as provided by Qifa Liu, Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • CMV and EBV reactivation rate [ Time Frame: 2 years ]
    Evaluation of CMV and EBV reactivation after chemotherapy combined with TKIs therapy in ALL patients


Secondary Outcome Measures:
  • The number of large granulosa cells and T、B、NK cell activity [ Time Frame: 2 years ]
    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


Estimated Enrollment: 100
Actual Study Start Date: November 1, 2017
Estimated Study Completion Date: September 1, 2019
Estimated Primary Completion Date: September 1, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chmotherapy combined with TKIs
Patients with ALL were treated by chmotherapy and TKIs(PDT-NFH-2016)
Drug: TKIs
Dasatinib combined with Chematherapy
Other Names:
  • Dasatinib
  • Nilotinib
  • Ponatinib
  • Imatinib

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331211


Contacts
Contact: Xutao Guo 008613802426709 ext 1 gxt827@126.com

Locations
China, Guangdong
Department of Hematology,Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Xutao Guo    008613802426709 ext 1    gxt827@126.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
  More Information

Publications:
Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03331211     History of Changes
Other Study ID Numbers: NFH-ALL-CMV-2017
First Submitted: October 31, 2017
First Posted: November 6, 2017
Last Update Posted: November 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qifa Liu, Nanfang Hospital of Southern Medical University:
Leukemia, Lymphoblastic, Acute

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action