Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Childhood Leukemia and Lymphoma Clinical Trial

Official title:

Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055558
• Other study ID #: RMC-0109-17
• Status: Recruiting
• Start date: August 25, 2019
• Est. completion date: March 18, 2022

Study information

• Verified date: August 2021
• Source: Rabin Medical Center
• Contact: Sarah Elitzur, MD
• Phone: 97239253669
• Email: sarhae[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 18, 2022
• Est. primary completion date: December 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• age>30 years

Related Conditions & MeSH terms

• Childhood Leukemia and Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoproliferative Disorders
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petah Tikva
Israel	Schneider Children's Medical Center	Petah Tikva

Sponsors (3)

Lead Sponsor	Collaborator
Rabin Medical Center	International BFM Study Group, Israeli Society for Pediatric Hematology-Oncology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability of survival	Assess six-month probability of survival since LPD diagnosis	1 year
Secondary	Event-free survival	Assess 5-year event-free survival since acute lymphoblastic leukemia/lymphoma diagnosis	5 years