Status:
COMPLETED
Targeted Radiotherapy in HSCT for Poor Risk Haematological Malignancy
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Royal Free and University College Medical School
Conditions:
Acute Leukaemia
Chronic Leukaemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ce...
Detailed Description
The aim of this clinical research study is to establish whether a radiolabelled antibody can be used to safely deliver radiotherapy to the bone marrow prior to stem cell transplantation for haematolog...
Eligibility Criteria
Inclusion
- 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.
- No concurrent or recent (within 3 weeks) chemotherapy for the underlying haematological condition
- For patients with relapsed leukaemia, bone marrow (BM) blasts must represent \< 20% of BM nucleated cells.
- Although the BM remission status is not important, patients must have cellularity \> 10%.
- 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.
- Age = or \>18 yrs.
- WHO performance status of 0, 1 or 2 (Appendix 5).
- Predicted life-expectancy of greater than four months.
- Patients must be negative for human anti-mouse antibodies (HAMA).
- 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)
- 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.
- Patient must be able to provide written informed consent.
Exclusion
- Any serious intercurrent disease.
- Patients with BM cellularity \< 10%.
- History of atopic asthma, eczema or allergy to rodent protein, confirmed history of severe allergic reactions to penicillin or streptomycin.
- Positive Human anti-murine antibodies (HAMA).
- Patients unable to provide informed consent or who are unable to co-operate for reasons of poor mental or physical health.
- Pregnancy
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01521611
Start Date
January 1 2002
End Date
July 1 2018
Last Update
April 8 2019
Active Locations (2)
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1
Southampton University Hospitals NHS Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
2
Royal Free Hospital and University College London
London, United Kingdom