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Completed

NCT Number: NCT01827579

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

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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Key information

Conditions

Haematological Malignancies Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University College London Hospital, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CD25/71 allodepleted donor T-cells

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

Primary outcomes

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

    Time frame: 4 months post transplant

Secondary outcomes

  1. Incidence of grade II-IV acute and chronic GVHD

    Time frame: 1 year post transplant

  2. 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

  3. In vitro anti-viral responses of circulating PBMC

    Time frame: 1 year post transplant

  4. Transplant related mortality at 1 year post-SCT

    Time frame: 1 year post transplant

  5. Disease-free survival at 1 year post-SCT

    Time frame: 1 year post transplant

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Medical Research Council

Registry information

Official study title

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

Acronym: ICAT

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2013
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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