NCT01827579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

5.5 years

First QC Date

April 4, 2013

Last Update Submit

July 18, 2022

Conditions

Haematological Malignancies

Keywords

TransplantCD25/71 allodepleted donor T cellsInfectionAcute Myeloid LeukaemiaAcute Lymphoblastic LeukaemiaAdultDiffuse Large B-Cell LymphomaMantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

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

    4 months post transplant

Secondary Outcomes (5)

  • 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

Study Arms (2)

CD25/71 allodepleted donor T-cells

EXPERIMENTAL

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

Control (normal HSCT)

NO INTERVENTION

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

Interventions

CD25/71 allodepleted donor T-cellsBIOLOGICAL

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

CD25/71 allodepleted donor T-cells

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Life expectancy \< 6 weeks
  • Female patients who are pregnant and lactating
  • Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University College London Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

MeSH Terms

Conditions

InfectionsLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinLymphoma

Study Officials

  • Persis Amrolia

    Great Ormond Street Hospital for Children NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2013

First Posted

April 9, 2013

Study Start

July 1, 2014

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

July 21, 2022

Record last verified: 2022-07

Locations

GB(2)