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

University College, London37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Haematological Malignancies

Interventions

CD25/71 allodepleted donor T-cellsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (2)

University College London Hospital

London, United Kingdom

Manchester Royal Infirmary

Manchester, United Kingdom

Outcomes

Primary Outcomes

Circulating CD3+ve T cell count at 4 months post-SCT

Time frame: 4 months post transplant