Clinical Trials /

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

NCT04082286

Description:

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).

Related Conditions:
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Juvenile Myelomonocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 07MI05
  • NCT ID: NCT04082286

Conditions

  • Acute Myeloblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Juvenile Myelomonocytic Leukemia

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
RadioimmunotherapyExperimentalChildren 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

    Eligibility Criteria

            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.
          
    Maximum Eligible Age:18 Years
    Minimum Eligible Age:1 Year
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:maximum tolerated dose (MTD)
    Time Frame:45 days post transplant
    Safety Issue:
    Description:targeted radiotherapy delivered by 90Yttrium-labelled anti-CD66

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Great Ormond Street Hospital for Children NHS Foundation Trust

    Last Updated