Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Graft vs Host Disease

Keywords

RuxolitinibT cells

Outcome Measures

Primary Outcomes (3)

Number of Participants with overall response rate.
Obtain ≥65% the overall response rate at 6 months after infusion
6 months post-infusion
Number of Participants with overall response rate.
Obtain ≥75% the overall response rate at 1 year after infusion
1 year post-infusion
Survival
Number of patients who survive after Regulatory T-cell enriched infusion
1 year after Regulatory T-cell enriched infusion

Secondary Outcomes (14)

Disease evaluation through Symptoms of the disease
Screening, weeks 1, 2, 4, 6, 12 and months 6, 9 and 12 months after infusion
Disease evaluation through measurement of quality of life
Screening, weeks 1, 2, 4, 6, 12 and months 6, 9 and 12 months after infusion
Disease evaluation through Symptoms of the disease
Screening, weeks 1, 2, 4, 6, 12 and months 6, 9 and 12 months after infusion
Immunosuppressive requirements.
Screening, month1, months 3, 6, and 12 after infusion
Free survival
1 year after infusion.
+9 more secondary outcomes

Study Arms (1)

Regulatory T-cell enriched infusion

EXPERIMENTAL

The doses of Regulatory T-cell enriched infusion will be 2x10\^6 cells/kg

Biological: Regulatory T-cell enriched infusion

Interventions

Regulatory T-cell enriched infusionBiological

Enrichment of cluster of differentiation 25hi regulatory T cells from cluster of differentiation antigen 8 and/or cluster of differentiation antigen19 pre-depleted leukapheresis products.

Regulatory T-cell enriched infusion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Otherlead

Study Sites (1)

José Antonio Pérez Simón

Seville, 41011, Spain

RECRUITING

José Antonio Pérez Simón, PhDCONTACTjosea.perez.simon.sspa@juntadeandalucia.es

Study Officials

José Antonio Pérez-Simón, M.D. Ph.D
Department of Hematology, Hospital Universitario Virgen del Rocío, Sevilla.
PRINCIPAL INVESTIGATOR

Central Study Contacts

José Antonio Pérez-Simón, M.D. Ph.D

CONTACT

955013414 josea.perez.simon.sspa@juntadeandalucia.es

Clara M. Rosso, M.D. Ph.D

CONTACT

955013414

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 26, 2021

First Posted

October 27, 2021

Study Start

March 24, 2022

Actual (reported)

Primary Completion

August 15, 2025

Donor Regulatory T-cells for cGVHD in Patients Who do Not Obtain Complete Remission With Ruxolitinib

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (14)

Study Arms (1)

Regulatory T-cell enriched infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (14)

Study Arms (1)

Regulatory T-cell enriched infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations