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

July 18, 2022 updated by: University College, London

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • University College London Hospital
      • Manchester, United Kingdom
        • Manchester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of grade II-IV acute and chronic GVHD
Time Frame: 1 year post transplant
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
Time Frame: 1 year post transplant
1 year post transplant
In vitro anti-viral responses of circulating PBMC
Time Frame: 1 year post transplant
1 year post transplant
Transplant related mortality at 1 year post-SCT
Time Frame: 1 year post transplant
1 year post transplant
Disease-free survival at 1 year post-SCT
Time Frame: 1 year post transplant
1 year post transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Medical Research Council

Investigators

  • Study Chair: Persis Amrolia, Great Ormond Street Hospital for Children NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 9, 2013

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCL/11/0519
  • 2013-000872-14 (EudraCT Number)
  • MR/K007491/1 (Other Grant/Funding Number: Medical Research Council)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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