Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Lymphoproliferative Disorders After Diagnosis of Childhood Acute Lymphoblastic Leukemia/Lymphoma

Sponsors

Lead Sponsor: Rabin Medical Center

Collaborator: The Israeli Society for Pediatric Hematology-Oncology
International BFM Study Group

Source Rabin Medical Center
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

Overall Status Recruiting
Start Date August 25, 2019
Completion Date March 18, 2022
Primary Completion Date December 18, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Probability of survival 1 year
Secondary Outcome
Measure Time Frame
Event-free survival 5 years
Enrollment 40
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- age>30 years

Gender: All

Minimum Age: N/A

Maximum Age: 30 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Sarah Elitzur, MD Principal Investigator Schneider Children's Medical Center
Overall Contact

Last Name: Sarah Elitzur, MD

Phone: 97239253669

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
Schneider Children's Medical Center | Petah Tikva, 4920235, Israel Recruiting Sarah Elitzur, MD 97239253669 [email protected]
Schneider Children's Medical Center | Petah Tikva, 4920235, Israel Recruiting Sarah Elitzur, MD [email protected]
Location Countries

Israel

Verification Date

August 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov