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

Sponsor

University College, London (Other)

Overall Status

Completed

CT.gov ID

NCT01827579

Collaborator

Medical Research Council (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

18.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Haematological Malignancies	Biological: CD25/71 allodepleted donor T-cells	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: 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
No Intervention: Control (normal HSCT) Patients randomised to the control arm with undergo stem cell transplantation according to site local practice.

Arm

Intervention/Treatment

Experimental: 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

Biological: 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

No Intervention: Control (normal HSCT)

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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