Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

NCT ID: NCT04055558

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-25
• Study Completion Date: 2022-03-18

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

Conditions

Childhood Leukemia and Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

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

• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Israeli Society for Pediatric Hematology-Oncology

OTHER

Sponsor Role: collaborator

International BFM Study Group

NETWORK

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Elitzur, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center

Locations

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sarah Elitzur, MD

Role: CONTACT

sarhae@clalit.org.il

97239253669

Naomi Litichever, PhD

Role: CONTACT

naomilitichever@clalit.org.il

97239253669

Facility Contacts

Sarah Elitzur, MD

Role: primary

sarhae@clalit.org.il

97239253669

Naomi Litichever, PhD

Role: backup

naomilitichever@clalit.org.il

97239253669

Sarah Elitzur, MD

Role: primary

sarhae@clalit.org.il

Naomi Litichever, PhD

Role: backup

naomilitichever@clalit.org.il

Other Identifiers

RMC-0109-17

Identifier Type: -

Identifier Source: org_study_id