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EBV-lymphoproliferative Disease During Treatment of Childhood Acute Lymphoblastic Leukemia/Lymphoma

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ClinicalTrials.gov Identifier: NCT04055558
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
The Israeli Society for Pediatric Hematology-Oncology
International BFM Study Group
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
Epstein Barr virus (EBV) associated lymphoproliferative disorder (LPD) is a major cause of morbidity and mortality in immunodeficient patients. There have been isolated case reports of patients with childhood ALL, who developed EBV-LPD during ALL therapy, without undergoing stem cell transplantation, but data regarding such cases are limited. We propose here an international collaboration, to form a comprehensive database of children who developed EBV-LPD during treatment of acute lymphoblastic leukemia/lymphoma

Condition or disease
Childhood Leukemia and Lymphoma

Detailed Description:

Epstein Barr virus (EBV) associated lymphoproliferative disorder (LPD) is a major cause of morbidity and mortality in immunodeficient patients. This disorder has been extensively described in the post-transplant setting, ie after hematopoietic stem cell (SCT) or solid organ (SOT) transplant. However, since the 1980's, there have been isolated case reports of patients with childhood ALL, who developed EBV-LPD during ALL therapy, without undergoing SCT. Comprehensive information is unavailable regarding the prevalence, clinical manifestations, treatment, outcome and pathogenesis of such disorders in this setting. We propose here an international collaboration, to form a comprehensive database of children who developed EBV-LPD during the treatment of acute lymphoblastic leukemia/lymphoma (ALL/LBL).

Information will be collected in a de-identified fashion regarding patient characteristics, leukemia and LPD characteristics, treatment and outcome. The aims of this retrospective study are:

  1. To build a database of children who developed EBV-LPD during the treatment of ALL/LBL
  2. To investigate the characteristics and outcome of this disorder

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EBV-lymphoproliferative Disease During Treatment of Childhood Acute Lymphoblastic Leukemia/Lymphoma
Estimated Study Start Date : August 18, 2019
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : March 18, 2020





Primary Outcome Measures :
  1. Probability of survival [ Time Frame: 1 year ]
    Assess six-month probability of survival since EBV-LPD diagnosis


Secondary Outcome Measures :
  1. Event-free survival [ Time Frame: 5 years ]
    Assess 5-year event-free survival since acute lymphoblastic leukemia/lymphoma diagnosis



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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and young adults (<30 years of age), previously diagnosed with acute lymphoblastic leukemia/lymphoma, who developed EBV-LPD during therapy.
Criteria

Inclusion Criteria:

  • Children and young adults treated for acute lymphoblasticleukemia/lymphoma who developed EBV-LPD during therapy

Exclusion Criteria:

  • age>30 years
  • Patients who developed EBV-LPD following stem cell transplantation

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): NCT04055558


Contacts
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Contact: Sarah Elitzur, MD 97239253669 sarhae@clalit.org.il
Contact: Naomi Litichever, PhD 97239253669 naomilitichever@clalit.org.il

Locations
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Israel
Schneider Children's Medical Center
Petah Tikva, Israel, 4920235
Sponsors and Collaborators
Rabin Medical Center
The Israeli Society for Pediatric Hematology-Oncology
International BFM Study Group
Investigators
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Principal Investigator: Sarah Elitzur, MD Schneider Children's Medical Center

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04055558     History of Changes
Other Study ID Numbers: RMC-0109-17
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Rabin Medical Center:
childhood leukemia
EBV lymphoproliferative disorders

Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases