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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Haematological Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

CD25/71 allodepleted donor T-cells

Intervention Type BIOLOGICAL

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

Control (normal HSCT)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No