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Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia

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

NCT04082286•Great Ormond Street Hospital for Children NHS Foundation Trust

View on ClinicalTrials.gov

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).

Eligibility

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. An underlying haematological malignancy including:
•1. isolated bone marrow relapse of AML after allogeneic haematopoietic stem cell transplantation;
•2. isolated bone marrow relapse of ALL after allogeneic haematopoietic stem cell transplantation;
•3. bone marrow relapse of JMML after allogeneic haematopoietic stem cell transplantation;
•4. refractory AML (5-20% blasts in BM) with/without expression of CD66 on blasts;
•5. refractory ALL (5-20% blasts in BM) with/without expression of CD66 on blasts;
•6. refractory AML (\> 20% blasts in BM) with expression of CD66 on blasts;
•7. refractory ALL (\> 20% blasts in BM) with expression of CD66 on blasts;
•2. be ≥ 1 year old and ≤ 18 years old;
•3. must not be eligible for therapy of higher curative potential. Where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study;
+6 more criteria

Exclusion Criteria

•1\) patients with CNS disease; 2) patients with BM cellularity \< 10%; 3) patients with ≥ 20% blasts in BM and no expression of CD66 on blasts; 4) patients who are positive for human-anti-murine antibodies (HAMA); 5) patients with compromised organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion; 6) patients with extensive chronic GvHD; 7) patients with an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment; 8) patients who are pregnant or lactating; 9) patients with any other severe concurrent disease, which, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

Locations (1)

Great Ormond Street Hospital for Children

London, United Kingdom

Key Dates

Start Date

May 1, 2016

Primary Completion Date

May 14, 2020

Completion Date

May 14, 2020

Last Updated

June 25, 2021

Enrollment

ACTUAL participants

Conditions

Acute Myeloblastic LeukemiaAcute Lymphoblastic LeukemiaJuvenile Myelomonocytic Leukemia

Interventions

Yttrium-90 labelled monoclonal antibody against CD66

OTHER

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NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia

Inclusion Criteria

Exclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

Venetoclax Basket Trial for High Risk Hematologic Malignancies

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies