Clinical trial · Interventional
Targeted Radiotherapy in HSCT for Poor Risk Haematological Malignancy
Radiolabelled Anti-CD66 Monoclonal Antibody in the Conditioning Regimen Prior to Haematopoietic Stem Cell Transplantation: Phase I Study in Patients With Poor-risk Disease.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine whether a radiolabelled antibody that targets the bone marrow (the 'anti-CD66') can be administered safely to patients as part of the preparative treatment prior to haematopoietic stem cell transplantation ('a bone marrow transplant'). Can the radiolabelled antibody be shown to effectively target the bone marrow in these patients. If it can, could this result in better outcomes after transplantation.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukaemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Chronic Leukaemia | Chronic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Targeted radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Targeted radiotherapy
- description
- Patients receive therapy with an yttrium-90 labelled anti-CD66 following favourable dosimetry with the same antibody radiolabelled with indium-111.
- interventionNames
- Radiation: Targeted radiotherapy
Primary outcomes (1)
- measure
- Toxicities related to radiolabelled antibody.
- timeFrame
- Up to 1 year post transplant World Health Organisation (WHO) toxicity criteria
- description
- To determine the maximum tolerated dose (MTD) of targeted radiotherapy delivered by a murine anti-CD66 monoclonal antibody radiolabelled with yttrium-90 (Y-90) and determine the dose-limiting toxicity (DLT) in patients with haematological malignancies who are undergoing haematopoietic stem cell transplantation. Toxicities are assessed using WHO Toxicity Scale with 28 parameters.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. An underlying haematological malignancy including acute myeloid leukaemia in first complete remission (CR1) but with poor prognostic features or in \>CR1 or in relapse; acute lymphoblastic leukaemia; transformed myelodysplasia, chronic myeloid leukaemia (accelerated phase or blast transformation, poor response or intolerance of tyrosine kinase inhibitors), myeloma. Patients may be in remission, partial remission or relapse.
2. No concurrent or recent (within 3 weeks) chemotherapy for the underlying haematological condition
3. For patients with relapsed leukaemia, bone marrow (BM) blasts must represent \< 20% of BM nucleated cells.
4. Although the BM remission status is not important, patients must have cellularity \> 10%.
5. As malignant plasma cells may or may not express CD66 antigens, patients with myeloma must have less than 30% plasma cells (as a percentage of total nucleated cells) in the BM at the time of the study.
6. Age = or \>18 yrs.
7. WHO performance status of 0, 1 or 2 (Appendix 5).
8. Predicted life-expectancy of greater than four months.
9. Patients must be negative for human anti-mouse antibodies (HAMA).
10. Peripheral blood counts:
Wbc \< 30 x 10e9/l (absolute neutrophil count \>0.5 x 10e9/L) platelets \> 50 x 10e9/l (platelet support is permitted)
11. Biochemical indices:
Plasma creatinine \< 120 micromol/l (or creatinine clearance or Ethylene diamine tetra acetic acid (EDTA) clearance \> 50 ml/min) Plasma bilirubin \< 30 micromol/l Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) no more than 2.5 x upper limit of the normal range.
12. Patient must be able to provide written informed consent.
Exclusion Criteria:
1. Any serious intercurrent disease.
2. Patients with BM cellularity \< 10%.
3. History of atopic asthma, eczema or allergy to rodent protein, confirmed history of severe allergic reactions to penicillin or streptomycin.
4. Positive Human anti-murine antibodies (HAMA).
5. Patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health.
6. PregnancyReferences
Publications (1)
- DERIVEDOrchard K, Langford J, Guy M, Lewis G, Michopoulou S, Cooper M, Zvavamwe C, Richardson D, Lewington V. Efficient bone marrow irradiation and low uptake by non-haematological organs with an yttrium-90-anti-CD66 antibody prior to haematopoietic stem cell transplantation. Bone Marrow Transplant. 2024 Sep;59(9):1247-1257. doi: 10.1038/s41409-024-02317-z. Epub 2024 Jun 12. PMID 38867006