International Leukemia Target Board

NCT05270096 | Recruiting

• 1 other identifier: MH21ILT, CRC 2019-062
• Study Type: observational
• Target: 600
• Locations: 7 countries
• Sites: 7

Brief Summary

The iLTB is a proof-of-concept initiative for children with r/r hematological malignancies, in which available treatment options will be prioritized by actionable events in a harmonized and uniform setting across Europe by a team of biologists, bio-statisticians, bio-informaticians, disease experts, geneticists, flow-experts, clinical trial physicians and also the treating physician. The iLTB will discuss molecular (genetic lesions), immunophenotypic/surface antigen markers information and, if available, drug response profiles to prioritize these events taking into account the treatment history and treatment intention (bridging to hematopoietic stem cell transplanation/CAR-T or palliative) of each patient followed by a registry to monitor how often iLTB advice has been followed, which other therapy was chosen (off-label, compassionate use) and what the patient outcome is at an aggregated level. As such the iLTB is non-interventional as it mainly provides advice and registers data on patients discussed in the iLTB.

Conditions

Refractory Hematologic Malignancy; Relapsed Hematologic Malignancy

Keywords

Tumor board; Relapsed leukemia; Treatment prioritization

Outcome Measures

Primary Outcomes (1)

• The proportion of patients receiving therapy according to the iLTB advice after providing the treating physician with a uniform prioritization of therapy options based on the patient's actionable events.

  through study completion, an average of 8 years

Secondary Outcomes (9)

• Harmonized algorithm to prioritize actionable events options in Europe

  through study completion, an average of 8 years

• Harmonized algorithm to prioritize treatment options in Europe is available

  through study completion, an average of 8 years

• Number and frequencies of different types of actionable events reported in the database

  through study completion, an average of 8 years

• Number of patients being treated with targeted agent according to iLTB advice and compare to previously reported literature by single molecular tumor board initiatives experience

  through study completion, an average of 8 years

• Calculate the time intervals between time to enrollment, time to recommendation, and time to treatment

  through study completion, an average of 8 years

Study Arms (1)

Relapsed leukemia

T-ALL: First relapse with high MRD after re-induction Newly diagnosed with high MRD after consolidation B-ALL: 1st relapse high risk group, Second or higher relapse, post CAR-T or post HSCT AML: Second or higher relapse

Other: Advice

Interventions

Advice OTHER

non-interventional study

Relapsed leukemia

Eligibility Criteria

• Age: 0 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children less than 18 years of age at the time of first diagnosis and less than 25 years at the time of inclusion with relapsed/refractory ALL, AML or LBL while being treated in a pediatric/AYA center, and for whom no standard of care treatment is available, and for whom molecular and flow cytometry profiling are available for iLTB discussion, and where the national group supports discussing the patient in the iLTB.

You may qualify if:

• The patient has been diagnosed with a R/R hematological malignancy;
• The patient is treated in a pediatric/AYA setting or study protocol, with no current standard of care treatment;
• The patients' life expectancy is at least 6 weeks;
• The patient has undergone any sort of molecular profiling of his/her tumor and the re-sults of this analysis are available;
• The patient has undergone flow cytometry in a certified lab and results are available;
• Written informed consent of patient and/or parent(s)/guardian(s) to discuss the patient in the iLTB according to local law and legislation has been obtained.

Sponsors & Collaborators

• Princess Maxima Center for Pediatric Oncology: lead

Study Sites (7)

UH Gent

Ghent, Belgium

RECRUITING

Righospitalet

Copenhagen, Denmark

RECRUITING

Semmelweis

Budapest, Hungary

RECRUITING

Princess Máxima Center for Pediatric Oncology

Utrecht, Utrecht, 3584CS, Netherlands

RECRUITING

Vall d'Hebron

Barcelona, Spain

RECRUITING

Queen Silvia

Gothenburg, Sweden

RECRUITING

Newcastle Hospital

Newcastle, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia

Interventions

Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Michel Zwaan, Prof. dr.

  Princess Maxima Center for Pediatric Oncology

  PRINCIPAL INVESTIGATOR

• Monique den Boer, Prof. dr.

  Princess Maxima Center for Pediatric Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uri Ilan, MD

CONTACT

+31889725206; iltb@prinsesmaximacentrum.nl

Anne Elsinghorst

CONTACT

+316 5000 6270; iltb@prinsesmaximacentrum.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 8, 2022
• Study Start: December 31, 2022
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): June 1, 2032
• Last Updated: January 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Request to iLTB steering committee

Locations

NL (1); ES (1); SE (1); GB (1); BE (1); DK (1); HU (1)