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Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Sponsor
Rabin Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04055558
Collaborator
Israeli Society for Pediatric Hematology-Oncology (Other), International BFM Study Group (Other)
40
Enrollment
2
Locations
30.8
Anticipated Duration (Months)
20
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lymphoproliferative disorders (LPD) are a major cause of morbidity and mortality in immunodeficient patients. There have been isolated case reports of patients with childhood ALL who developed LPD after ALL diagnosis, 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 LPD after diagnosis of acute lymphoblastic leukemia/lymphoma

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Lymphoproliferative disorders (LPD) are a major cause of morbidity and mortality in immunodeficient patients. These disorders have 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 LPD after diagnosis of ALL, 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 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 LPD after diagnosis of ALL/LBL

    2. To investigate the characteristics and outcome of this disorder

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma
    Actual Study Start Date :
    Aug 25, 2019
    Anticipated Primary Completion Date :
    Dec 18, 2021
    Anticipated Study Completion Date :
    Mar 18, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Probability of survival [1 year]

      Assess six-month probability of survival since LPD diagnosis

    Secondary Outcome Measures

    1. Event-free survival [5 years]

      Assess 5-year event-free survival since acute lymphoblastic leukemia/lymphoma diagnosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children and young adults treated for acute lymphoblasticleukemia/lymphoma who developed LPD after ALL/LBL diagnosis
    Exclusion Criteria:
    • age>30 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schneider Children's Medical Center Petah Tikva Israel 4920235
    2 Schneider Children's Medical Center Petah Tikva Israel 4920235

    Sponsors and Collaborators

    • Rabin Medical Center
    • Israeli Society for Pediatric Hematology-Oncology
    • International BFM Study Group

    Investigators

    • Principal Investigator: Sarah Elitzur, MD, Schneider Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT04055558
    Other Study ID Numbers:
    • RMC-0109-17
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Oct 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    lymphoproliferative disorders
    EBV
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Lymphoproliferative Disorders

    Study Results

    No Results Posted as of Oct 1, 2021