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

Primary Purpose

Haematological Malignancies

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

CD25/71 allodepleted donor T-cells

About this trial

This is an interventional prevention trial for Haematological Malignancies focused on measuring Transplant, CD25/71 allodepleted donor T cells, Infection, Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Adult, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University College London Hospital
Manchester Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CD25/71 allodepleted donor T-cells

Control (normal HSCT)

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of grade II-IV acute and chronic GVHD

Time to recovery of normal T-cell (>700/uL) and CD4 (>300/uL) counts and normal TCR diversity as assessed by Vb spectratyping

In vitro anti-viral responses of circulating PBMC

Transplant related mortality at 1 year post-SCT

Disease-free survival at 1 year post-SCT

Full Information

NCT ID

NCT01827579

First Posted

April 4, 2013

Last Updated

July 18, 2022

Sponsor

University College, London

Collaborators

Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT01827579

Brief Title

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

Acronym

ICAT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

January 2020 (Actual)

Study Completion Date

January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College, London

Collaborators

Medical Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haematological Malignancies

Keywords

Transplant, CD25/71 allodepleted donor T cells, Infection, Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Adult, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CD25/71 allodepleted donor T-cells

Arm Type

Experimental

Arm 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

Arm Title

Control (normal HSCT)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

CD25/71 allodepleted donor T-cells

Intervention 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

Primary Outcome Measure Information:

Title

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

Time Frame

4 months post transplant

Secondary Outcome Measure Information:

Title

Incidence of grade II-IV acute and chronic GVHD

Time Frame

1 year post transplant

Title

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

Title

In vitro anti-viral responses of circulating PBMC

Time Frame

1 year post transplant

Title

Transplant related mortality at 1 year post-SCT

Time Frame

1 year post transplant

Title

Disease-free survival at 1 year post-SCT

Time Frame

1 year post transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Persis Amrolia

Organizational Affiliation

Great Ormond Street Hospital for Children NHS Foundation Trust

Official's Role

Study Chair

Facility Information:

Facility Name

University College London Hospital

City

London

Country

United Kingdom

Facility Name

Manchester Royal Infirmary

City

Manchester

Country

United Kingdom

12. IPD Sharing Statement

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

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