Completed
ICATAdoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
What is being tested
CD25/71 allodepleted donor T-cells
Biological
Who is being recruted
Hematologic Diseases+16
+ Hemic and Lymphatic Diseases
+ Immune System Diseases
Over 16 Years
+7 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 1 & 2
Interventional
Study Start: July 2014
Summary
Principal SponsorUniversity College, London
Last updated: July 21, 2022
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2014
Actual date on which the first participant was enrolled.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.
Principal SponsorUniversity College, London
Last updated: July 21, 2022
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
37 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-CellInfectionsLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-Lymphoma
Criteria
4 inclusion criteria required to participate
Age >= 16 years
Planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 HLA matched unrelated donor, using an Alemtuzumab-based conditioning protocol
Underlying haematological malignancy
Written Informed consent
3 exclusion criteria prevent from participating
Female patients who are pregnant and lactating
Life expectancy < 6 weeks
Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalCD25/71 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 II
No InterventionPatients randomised to the control arm with undergo stem cell transplantation according to site local practice.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
University College London Hospital
London, United KingdomOpen University College London Hospital in Google MapsManchester Royal Infirmary
Manchester, United KingdomCompleted2 Study Centers