NCT04055558

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

August 25, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2022

Completed
Last Updated

October 1, 2021

Status Verified

August 1, 2021

Enrollment Period

2.3 years

First QC Date

August 11, 2019

Last Update Submit

September 30, 2021

Conditions

Childhood Leukemia and Lymphoma

Keywords

childhood leukemialymphoproliferative disordersEBV

Outcome Measures

Primary Outcomes (1)

  • Probability of survival

    Assess six-month probability of survival since LPD diagnosis

    1 year

Secondary Outcomes (1)

  • Event-free survival

    5 years

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • age\>30 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Schneider Children's Medical Center

Petah Tikva, 4920235, Israel

RECRUITING

Schneider Children's Medical Center

Petah Tikva, 4920235, Israel

RECRUITING

MeSH Terms

Conditions

LymphomaLymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Sarah Elitzur, MD

    Schneider Children's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Elitzur, MD

CONTACT

97239253669sarhae@clalit.org.il

Naomi Litichever, PhD

CONTACT

97239253669naomilitichever@clalit.org.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2019

First Posted

August 13, 2019

Study Start

August 25, 2019

Primary Completion

December 18, 2021

Study Completion

March 18, 2022

Last Updated

October 1, 2021

Record last verified: 2021-08

Locations

IL(2)