Infusion of Depleted T Cells Following Unrelated Donor Stem Cell Transplant (ICAT)
Phase 1
Completed
- Conditions
- Haematological Malignancies
- Registration Number
- NCT01827579
- Lead Sponsor
- University College, London
- Brief Summary
The purpose of this study is to evaluate whether the administration of allodepleted donor T cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- Age ≥16 years
- Underlying haematological malignancy
- Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
- Written Informed consent
Exclusion Criteria
- Life expectancy < 6 weeks
- Female patients who are pregnant and lactating
- Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Circulating CD3+ve T cell count at 4 months post-SCT 4 months post transplant
- Secondary Outcome Measures
Name Time Method Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping 1 year post transplant Incidence of grade II-IV acute and chronic GVHD 1 year post transplant Disease-free survival at 1 year post-SCT 1 year post transplant Transplant related mortality at 1 year post-SCT 1 year post transplant In vitro anti-viral responses of circulating PBMC 1 year post transplant
Trial Locations
- Locations (2)
University College London Hospital
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
University College London Hospital🇬🇧London, United Kingdom