Status:
COMPLETED
Yttrium-90 Anti CD66 Monoclonal Antibody in Childhood Relapsed/Refractory Leukaemia
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
Acute Myeloblastic Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04082286
Start Date
May 1 2016
End Date
May 14 2020
Last Update
June 25 2021
Active Locations (1)
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1
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N3JH