Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD

Chronic GVHD After HCT for Cancer or Immune Disease Clinical Trial

— CARE  

Official title:

Continuous Alloreactive T Cell Depletion and Regulatory T Cell Expansion for the Treatment of Steroid-refractory or Dependent Chronic GVHD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02519816
• Other study ID #: CNTRP 1401
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: January 1, 2020

Study information

• Verified date: August 2019
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Primary objective is to measure the efficacy of CARE (Continuous Alloreactive T-Cell depletion and Regulatory T-cell Expansion)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria: (Main)

• 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.

Exclusion Criteria: (Main)

• 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

Related Conditions & MeSH terms

• Chronic GVHD After HCT for Cancer or Immune Disease
• Immune System Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Hospital Maissoneuve	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
daphne brockington

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is failure-free survival (FFS) at 24 weeks		24 weeks