Infusion of Depleted T Cells Following Unrelated Donor Stem Cell Transplant (ICAT)

Study Overview
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Brief Summary
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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.

Official Title
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Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant

Conditions
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Haematological Malignancies

Intervention / Treatment
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* Biological: CD25/71 allodepleted donor T-cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CD25/71 allodepleted donor T-cells<br>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<br>* 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<br>|
| No Intervention: Control (normal HSCT)<br>Patients randomised to the control arm with undergo stem cell transplantation according to site local practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating CD3+ve T cell count at 4 months post-SCT |  | 4 months post transplant | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplant, CD25/71 allodepleted donor T cells, Infection, Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Adult, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma