Haematological MalignanciesPhase 1/2ICATNCT01827579
Infusion of Depleted T Cells Following Unrelated Donor Stem Cell Transplant (ICAT)
A Phase 1/2 study testing CD25/71 allodepleted donor T-cells in people with Haematological Malignancies, run by University College, London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Haematological Malignancies
- What is being tested?
- CD25/71 allodepleted donor T-cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2014to Jan 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Life expectancy < 6 weeks
- Female patients who are pregnant and lactating
- Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University College London Hospital
London
Manchester Royal Infirmary
Manchester
About this study
Official title: Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
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.
- Conditions
- Haematological Malignancies
- Being tested
- CD25/71 allodepleted donor T-cells
- Keywords
- Transplant, CD25/71 allodepleted donor T cells, Infection, Acute Myeloid Leukaemia, Acute Lymphoblastic Leukaemia, Adult, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma
- Medical subject headings
- Infections, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating CD3+ve T cell count at 4 months post-SCT
Measured: 4 months post transplant
Secondary outcomes (5)
Incidence of grade II-IV acute and chronic GVHD
Measured: 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
Measured: 1 year post transplant
In vitro anti-viral responses of circulating PBMC
Measured: 1 year post transplant
Transplant related mortality at 1 year post-SCT
Measured: 1 year post transplant
Disease-free survival at 1 year post-SCT
Measured: 1 year post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJul 2014
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignanciesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Persis Amrolia, Study chair, Great Ormond Street Hospital for Children NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827579
- Sponsor's protocol ID
- UCL/11/0519
- Other IDs
- 2013-000872-14, MR/K007491/1
- Acronym
- ICAT
- Status last verified
- Jul 2022
- First submitted
- 4 Apr 2013
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoptive Immunotherapy With CD25/71 Allodepleted Donor T Cells to Improve Immunity After Unrelated Donor Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT01827579
- Acronym / sponsor ID
- ICAT / UCL/11/0519
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Jul 2014 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD25/71 allodepleted donor T-cells | Experimental | Biological: CD25/71 allodepleted donor T-cellsCD25/71 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) | No intervention | –Patients randomised to the control arm with undergo stem cell transplantation according to site local practice. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Life expectancy < 6 weeks
- Female patients who are pregnant and lactating
- Patients who are serologically positive for Hepatitis B, C or HIV pre-SCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD25/71 allodepleted donor T-cellsCD25/71 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 |
Primary outcome
Circulating CD3+ve T cell count at 4 months post-SCT
Time frame: 4 months post transplant
5 secondary outcomes
Incidence of grade II-IV acute and chronic GVHD
Time frame: 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
Time frame: 1 year post transplant
In vitro anti-viral responses of circulating PBMC
Time frame: 1 year post transplant
Transplant related mortality at 1 year post-SCT
Time frame: 1 year post transplant
Disease-free survival at 1 year post-SCT
Time frame: 1 year post transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Persis Amrolia study chair
Great Ormond Street Hospital for Children NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD25/71 allodepleted donor T-cells in people with Haematological Malignancies, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating CD3+ve T cell count at 4 months post-SCT (time frame: 4 months post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.