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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000872-14 | EudraCT Number | ||
| MR/K007491/1 | Other Grant/Funding Number | Medical Research Council |
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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD25/71 allodepleted donor T-cells | Experimental | 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 |
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| Control (normal HSCT) | No Intervention | Patients randomised to the control arm with undergo stem cell transplantation according to site local practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD25/71 allodepleted donor T-cells | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating CD3+ve T cell count at 4 months post-SCT | 4 months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grade II-IV acute and chronic GVHD | 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 | 1 year post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Persis Amrolia | Great Ormond Street Hospital for Children NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital | London | United Kingdom | ||||
| Manchester Royal Infirmary |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| In vitro anti-viral responses of circulating PBMC | 1 year post transplant |
| Transplant related mortality at 1 year post-SCT | 1 year post transplant |
| Disease-free survival at 1 year post-SCT | 1 year post transplant |
| Manchester |
| United Kingdom |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |