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

Phase 1

Completed

• Conditions: Haematological Malignancies
• Interventions: Biological: CD25/71 allodepleted donor T-cells

• Registration Number: NCT01827579
• Lead Sponsor: University College, London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Study Start: 2014-07
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD25/71 allodepleted donor T-cells	CD25/71 allodepleted donor T-cells	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

Primary Outcome Measures

Name	Time	Method
Circulating CD3+ve T cell count at 4 months post-SCT	4 months post transplant

Secondary Outcome Measures

Name	Time	Method
Incidence of grade II-IV acute and chronic GVHD	1 year post transplant
Transplant related mortality at 1 year post-SCT	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
Disease-free survival at 1 year post-SCT	1 year post transplant

Trial Locations

Locations (2)

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

University College London Hospital; 🇬🇧 London, United Kingdom