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

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;