A Phase 1/2 interventional study of CD25/71 allodepleted donor T-cells in Haematological Malignancies, sponsored by University College, London. Completed at 2 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-07-21.
Sponsored by University College, London · Phase 1/2, Interventional, and Prevention
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.
6,702 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's enrollment of 37 is below the median of 120 across 4,205 interventional studies indexed under Infections.
Browse Infections studies →University College, London is the lead sponsor of 647 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
CD25/71 allodepleted donor T-cells will be administered at a dose of 10\^5 /kg at day 30 post-SCT, 3 x 10\^5 /kg at day 60 and 10\^6 /kg at day 90 post transplant
Biological: CD25/71 allodepleted donor T-cells
Patients randomised to the control arm with undergo stem cell transplantation according to site local practice.
CD25/71 allodepleted donor T-cells will be administered at a dose of 10\^5 /kg at day 30 post-SCT, 3 x 10\^5 /kg at day 60 and 10\^6 /kg at day 90 post transplant
Circulating CD3+ve T cell count at 4 months post-SCT
Time frame: 4 months post transplant
Incidence of grade II-IV acute and chronic GVHD
Time frame: 1 year post transplant
Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping
Time frame: 1 year post transplant
In vitro anti-viral responses of circulating PBMC
Time frame: 1 year post transplant
Transplant related mortality at 1 year post-SCT
Time frame: 1 year post transplant
Disease-free survival at 1 year post-SCT
Time frame: 1 year post transplant
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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