Clinical trial NCT04055558: Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma
Official title: Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Leukemia and Lymphoma
Keywords: childhood leukemia
lymphoproliferative disorders
EBV
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Israeli Society for Pediatric Hematology-Oncology
name: International BFM Study Group
First posted: 2019-08-13
Enrollment: 40
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults (\<30 years of age), previously diagnosed with acute lymphoblastic leukemia/lymphoma, who developed LPD after ALL/LBL diagnosis

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

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

Eligibility criteria: Inclusion Criteria:

* Children and young adults treated for acute lymphoblasticleukemia/lymphoma who developed LPD after ALL/LBL diagnosis

Exclusion Criteria:

* age\>30 years

Primary outcomes:
measure: Probability of survival
timeFrame: 1 year
Secondary outcomes:
measure: Event-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider Children's Medical Center
name: Sarah Elitzur, MD
role: PRINCIPAL_INVESTIGATOR
References: