Back to results

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

Primary Purpose

Acute Myeloblastic Leukemia, Acute Lymphoblastic Leukemia, Juvenile Myelomonocytic Leukemia

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Yttrium-90 labelled monoclonal antibody against CD66

About this trial

This is an interventional treatment trial for Acute Myeloblastic Leukemia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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;
be ≥ 1 year old and ≤ 18 years old;
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;
have a Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30;
provide signed, written informed consent from parent or guardian;
be able to comply with study procedures and follow-up examinations;
have normal cardiac function without specific treatment;
have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion;
patients who have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrolment;
be negative for human-anti-murine antibodies (HAMA). 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.

Sites / Locations

Great Ormond Street Hospital for Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radioimmunotherapy

Arm Description

Children affected by high risk malignant disorders will be receiving increasing infused activity of a radio-immune conjugated antibody as part of their conditioning regimen prior to alleogeneic stem cell transplantation

Outcomes

Primary Outcome Measures

maximum tolerated dose (MTD)

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

dose limited toxicity (DLT)

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

Secondary Outcome Measures

Full Information

NCT ID

NCT04082286

First Posted

September 5, 2019

Last Updated

June 24, 2021

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT04082286

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

May 14, 2020 (Actual)

Study Completion Date

May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloblastic Leukemia, Acute Lymphoblastic Leukemia, Juvenile Myelomonocytic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

3+3 Dose escalation study, patient will receive 111In-labelled anti-CD66 MoAb (dosimetry) and 90Yttrium-labelled anti-CD66 MoAb (for therapy)

Masking

None (Open Label)

Masking Description

Yttrium-90 labelled monoclonal antibody against CD66

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radioimmunotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Yttrium-90 labelled monoclonal antibody against CD66

Other Intervention Name(s)

Radioimmunotherapy

Primary Outcome Measure Information:

Title

maximum tolerated dose (MTD)

Description

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

Time Frame

45 days post transplant

Title

dose limited toxicity (DLT)

Description

targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

Time Frame

45 days post transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: An underlying haematological malignancy including: isolated bone marrow relapse of AML after allogeneic haematopoietic stem cell transplantation; isolated bone marrow relapse of ALL after allogeneic haematopoietic stem cell transplantation; bone marrow relapse of JMML after allogeneic haematopoietic stem cell transplantation; refractory AML (5-20% blasts in BM) with/without expression of CD66 on blasts; refractory ALL (5-20% blasts in BM) with/without expression of CD66 on blasts; refractory AML (> 20% blasts in BM) with expression of CD66 on blasts; refractory ALL (> 20% blasts in BM) with expression of CD66 on blasts; be ≥ 1 year old and ≤ 18 years old; 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; have a Karnofsky Performance Status ≥ 50 or Lansky Performance Status ≥ 30; provide signed, written informed consent from parent or guardian; be able to comply with study procedures and follow-up examinations; have normal cardiac function without specific treatment; have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion; patients who have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrolment; be negative for human-anti-murine antibodies (HAMA). 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.

Facility Information:

Facility Name

Great Ormond Street Hospital for Children

City

London

ZIP/Postal Code

WC1N3JH

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs