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90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia - Trial NCT04856215

Access comprehensive clinical trial information for NCT04856215 through Pure Global AI's free database. This Phase 2 trial is sponsored by Great Ormond Street Hospital for Children NHS Foundation Trust and is currently Not yet recruiting. The study focuses on Leukemia. Target enrollment is 25 participants.

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NCT04856215
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04856215
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90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia
90Yttrium-labelled Anti-CD66 Monoclonal Antibody as Part of a Reduced Toxicity Conditioning Regimen Prior to Allogeneic Haematopoietic Stem Cell Transplantation: an Open Label, Phase II Study in Children and Adolescents With High Risk Leukaemia

Study Focus

Leukemia

90-Yttrium-labelled anti-CD66 monoclonal antibody

Interventional

drug

Sponsor & Location

Great Ormond Street Hospital for Children NHS Foundation Trust

Timeline & Enrollment

Phase 2

Jan 01, 2022

Jun 01, 2024

25 participants

Primary Outcome

Disease response after [90Y]-labelled anti-CD66 monoclonal antibody

Summary

Children affected by high risk or relapsed/refractory leukaemia have a poor prognosis, with
 an increased risk of relapse. These patients generally need treatment intensification and a
 bone marrow transplantation (BMT).
 
 Nevertheless, with conventional treatent the risk of relapse after transplant remains high.
 
 Radioimmunotherapy provides a way to deliver high dose irradiation to the bone marrow (where
 leukaemia resides), while sparing normal organs and tissues from its toxicity.This can be
 achieved by linking a radioactive molecule (Yttrium90) to an antibody that, once infused in
 the blood, targets marrow/leukemic cells.

ICD-10 Classifications

Leukaemia, unspecified
Myeloid leukaemia
Myeloid leukaemia, unspecified
Other myeloid leukaemia
Monocytic leukaemia, unspecified

Data Source

ClinicalTrials.gov

NCT04856215

Non-Device Trial