Chronic GVHD After HCT for Cancer or Immune DiseasePhase 2CARENCT02519816
Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
A Phase 2 study testing Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte. in people with Chronic GVHD After HCT for Cancer or Immune Disease, run by daphne brockington at 1 site in Canada.
Trial summary
Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease. Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic GVHD After HCT for Cancer or Immune Disease
- What is being tested?
- Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to 1 Jan 2020
- Phase
- Phase 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.
- AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):
- Progression on prednisone 7 mg/kg/week for 2 weeks, or
- Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
- Inability to taper prednisone below 3.5 mg/kg/week.
Who cannot join
- 1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.
- OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.
- OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.
- OR 4. Time from allogeneic transplantation > 2 years. OR 5. Lymphocyte count < 0.2 x 109/L on two last consecutive CBCs before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease.
Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)
- Being tested
- Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.
- Keywords
- post stem cell transplantation, Steroid refractory, dependent chronic
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.Other
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Open-label phase II study. After signing informed consent, patients will undergo 6 times an apheresis during the 6-month treatment period. These cells will be manufactured into the Rhitol and frozen in aliquots. Then re-infused. Receives: Other: Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is failure-free survival (FFS) at 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startMar 2016
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic GVHD After HCT for Cancer or Immune DiseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- daphne brockington
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, daphne brockington, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519816
- Sponsor's protocol ID
- CNTRP 1401
- Acronym
- CARE
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2015
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD
- ClinicalTrials.gov ID
- NCT02519816
- Acronym / sponsor ID
- CARE / CNTRP 1401
- Keywords
- post stem cell transplantation, Steroid refractory, dependent chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- daphne brockingtonUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 11 Aug 2015 (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.
Phase II multicenter, Canadian only study - open to 25 subjects. Study open to subjects with steroid-refractory or dependent chronic graft vs host disease.
Series of 6 aphereses and 28 re-infusions over 24 weeks. Primary endpoint is FFS at 24 weeks. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.Open-label phase II study. After signing informed consent, patients will undergo 6 times an apheresis during the 6-month treatment period. These cells will be manufactured into the Rhitol and frozen in aliquots. Then re-infused. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids.
- AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following):
- Progression on prednisone 7 mg/kg/week for 2 weeks, or
- Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or
- Inability to taper prednisone below 3.5 mg/kg/week.
Key exclusion criteria (4 listed)
- 1. Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD.
- OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD.
- OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment.
- OR 4. Time from allogeneic transplantation > 2 years. OR 5. Lymphocyte count < 0.2 x 109/L on two last consecutive CBCs before inclusion
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 |
|---|---|---|
| Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte. | Other | Intervention |
Primary outcome
The primary endpoint is failure-free survival (FFS) at 24 weeks
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte. in people with Chronic GVHD After HCT for Cancer or Immune Disease, run by daphne brockington at 1 site in Canada.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 phase mean?
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?
Results are not available in the source record.
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?
The primary endpoint is failure-free survival (FFS) at 24 weeks (time frame: 24 weeks). 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 14 Aug 2019.