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Clinical Trials/NCT04082286
NCT04082286CompletedPhase 1

90Yttrium-labelled Anti-CD66 Monoclonal Antibody as Part of a Reduced Intensity Conditioning Regimen Prior to Allogeneic Haematopoietic Stem Cell Transplantation: an Open Label, Dose Escalating Phase I Study in Children and Adolescents With Relapsed/Refractory Leukaemia

Great Ormond Street Hospital for Children NHS Foundation Trust2 sites in 1 country9 target enrollmentStarted: May 2016Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
9
Locations
2
Primary Endpoint
maximum tolerated dose (MTD)

Study Overview

Brief Summary

The radio-labeled anti-CD66 monoclonal antibody (with 111In for dosimetry and 90Y for therapy) will be administered in the T11 North room, UCLH, while the reduced intensity conditioning regimen and the allogeneic hematopoietic stem cell transplant will be performed in 2 centers, according to the age of the patient: A) patients aged < 13 years will be transplanted at the Bone Marrow Transplantation Department, Great Ormond Street Hospital (GOSH), and B) patients aged 13-18 years will be transplanted at the Bone Marrow Transplantation Department, University College London Hospitals (UCLH).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

Yttrium-90 labelled monoclonal antibody against CD66

Eligibility Criteria

Ages
1 Year to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

maximum tolerated dose (MTD)

Time Frame: 45 days post transplant

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

dose limited toxicity (DLT)

Time Frame: 45 days post transplant

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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