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

University College London (UCL)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Haematological Malignancies

Treatments: Biological: CD25/71 allodepleted donor T-cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01827579

MR/K007491/1 (Other Grant/Funding Number)

2013-000872-14 (EudraCT Number)

UCL/11/0519

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

CD25/71 allodepleted donor T-cells

Experimental group

Description:

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

Treatment:

Biological: CD25/71 allodepleted donor T-cells

Control (normal HSCT)

No Intervention group

Description:

Patients randomised to the control arm with undergo stem cell transplantation according to site local practice.