Phase II Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in Patients Who do Not Obtain Complete Remission With Ruxolitinib

Who is this study for? Recipients of allogeneic hematopoietic stem cell transplantation
What treatments are being studied? Regulatory T-cell enriched infusion
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Phase II clinical trial to assess the efficacy of donor regulatory enriched T cells in steroid-refractory chronic graft versus host disease patients who did not obtain complete remission under treatment with ruxolitinib

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Recipient of allogeneic hematopoietic stem cell transplantation

• Participants must have steroid-refractory cGVHD and had obtained any response other than progression after at least 12 weeks of treatment with ruxolitinib. Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate glucocorticoids) without complete resolution of signs and symptoms.

• Stable dose of glucocorticoids for 4 weeks prior to enrollment.

• No addition or subtraction of other immunosuppressive medications (e.g., calcineurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrollment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug.

• No age limit. In the case of children participating in the study, the informed consent will be signed by a parents or legal guardians.

• Eastern Cooperative Oncology Group scale performance status 0-2

• Participants must have adequate organ function

• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

• Ability to understand and the willingness to sign a written informed consent document

Locations
Other Locations
Spain
José Antonio Pérez Simón
RECRUITING
Seville
Contact Information
Primary
José Antonio Pérez-Simón, M.D. Ph.D
josea.perez.simon.sspa@juntadeandalucia.es
955013414
Backup
Clara M. Rosso, M.D. Ph.D
claram.rosso.sspa@juntadeandalucia.es
955013414
Time Frame
Start Date: 2022-03-24
Estimated Completion Date: 2026-02-15
Participants
Target number of participants: 15
Treatments
Experimental: Regulatory T-cell enriched infusion
The doses of Regulatory T-cell enriched infusion will be 2x10\^6 cells/kg
Sponsors
Leads: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

This content was sourced from clinicaltrials.gov

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