NCT05639673

Brief Summary

The goal of this observational study is to quantify the burden of particularly severe, long-term adverse effects in childhood acute lymphoblastic leukemia (ALL) survivors. The adverse effects include 21 severe health conditions recently selected and defined as Severe Toxicities by an international collaboration of ALL consortia. The main questions the study aims to answer for childhood ALL patients are:

  • What is the chance of surviving without any Severe Toxicities during the first 5 years after ALL diagnosis?
  • What is the average cumulative burden of different Severe Toxicities during the first 5 years after ALL diagnosis? The study uses standard-care follow-up data for childhood ALL patients from an international collaboration of five ALL consortia from Europe, the US, and Australia.

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
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

November 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

1.4 years

First QC Date

November 24, 2022

Last Update Submit

May 25, 2023

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

  • Severe-Toxicity-Free Survival

    Time from ALL diagnosis to the first event of a Severe Toxicity or death

    Within 5 years after ALL diagnosis

  • Number of different Severe Toxicities

    Temporal development of cumulative number of Severe Toxicities

    Within 5 years after ALL diagnosis

Other Outcomes (1)

  • Occurrence of 21 Severe Toxicities

    Within 5 years after ALL diagnosis

Study Arms (5)

NOPHO ALL2008

Children and adolescents treated according to the NOPHO ALL2008 protocol

Australia

Poland

Dutch Childhood Oncology Group

St. Jude

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents treated for acute lymphoblastic leukemia

You may qualify if:

  • Diagnosed with ALL ≥5 years ago
  • \<18 years of age at time of ALL diagnosis

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kjeld Schmiegelow

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (2)

  • Andres-Jensen L, Attarbaschi A, Bardi E, Barzilai-Birenboim S, Bhojwani D, Hagleitner MM, Halsey C, Harila-Saari A, van Litsenburg RRL, Hudson MM, Jeha S, Kato M, Kremer L, Mlynarski W, Moricke A, Pieters R, Piette C, Raetz E, Ronceray L, Toro C, Grazia Valsecchi M, Vrooman LM, Weinreb S, Winick N, Schmiegelow K; Ponte di Legno Severe Toxicity Working Group. Severe toxicity free survival: physician-derived definitions of unacceptable long-term toxicities following acute lymphocytic leukaemia. Lancet Haematol. 2021 Jul;8(7):e513-e523. doi: 10.1016/S2352-3026(21)00136-8.

    PMID: 34171282BACKGROUND

  • Nielsen CG, Thomsen BL, Als-Nielsen B, Conyers R, Jeha S, Mateos MK, Mlynarski W, Pieters R, Rathe M, Schmiegelow K, Andres-Jensen L. Physician-defined severe toxicities occurring during and after cancer treatment: Modified consensus definitions and clinical applicability in the evaluation of cancer treatment. Front Pediatr. 2023 Apr 26;11:1155449. doi: 10.3389/fped.2023.1155449. eCollection 2023.

    PMID: 37181427BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Kjeld Schmiegelow, DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camilla Grud Nielsen, MD

CONTACT

+4528450302camilla.grud.nielsen@regionh.dk

Kjeld Schmiegelow, DMSc

CONTACT

+4535451357kjeld.schmiegelow@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 6, 2022

Study Start

June 15, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2025

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

DK(1)