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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04082286
Other study ID # 07MI05
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2016
Est. completion date May 14, 2020

Study information

Verified date October 2020
Source Great Ormond Street Hospital for Children NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date May 14, 2020
Est. primary completion date May 14, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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; 4. have a Karnofsky Performance Status = 50 or Lansky Performance Status = 30; 5. provide signed, written informed consent from parent or guardian; 6. be able to comply with study procedures and follow-up examinations; 7. have normal cardiac function without specific treatment; 8. have adequate organ function (as indicated by Table 3, chapter 5), within 30 days prior to 111In infusion; 9. 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; 10. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Yttrium-90 labelled monoclonal antibody against CD66


Locations

Country Name City State
United Kingdom Great Ormond Street Hospital for Children London

Sponsors (1)

Lead Sponsor Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary maximum tolerated dose (MTD) targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66 45 days post transplant
Primary dose limited toxicity (DLT) targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66 45 days post transplant
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