Immuno-regulatory Profiling of T Cells in GVHD Treated With Extracorporeal Photopheresis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-26

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Extracorporeal Photopheresis (ECP) has been used as one of the treatments for graft versus host disease (GVHD). Responses were observed in skin, liver, GI tract, mouth, eye and lung. ECP does not cause immune suppression and therefore less risk of infection or relapse of malignancy. However, the exact mechanism of action of this expensive procedure is not fully understood and no predictors of response to ECP are known so far. This reflects the need for a better understanding of GVHD and its response to ECP. Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using flow cytometer

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC

NCT02065362

EBV-positive Nasopharyngeal Carcinoma

ACTIVE_NOT_RECRUITING PHASE1

Phase I Study of OriC902 in Treatment of Advanced HCC

NCT06891742

HCC

RECRUITING PHASE1

Blood T-Cells and EBV Specific CTLs Expressing GD-2 Specific Chimeric T Cell Receptors to Neuroblastoma Patients

NCT00085930

Neuroblastoma

COMPLETED PHASE1

Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant

NCT04815356

Hairy Cell Leukemia Hairy Cell Leukemia Variant

RECRUITING PHASE1

Biological Therapy in Treating Patients With Advanced Cancer

NCT00005956

Breast Cancer Gastric Cancer Ovarian Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

GVHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ECP

Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer

blood samples

Intervention Type OTHER

Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood samples

Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients who are recipients of allogeneic stem cell grafts.
2. Patients with the diagnosis of GVHD according to established criteria and physician decides to treat using ECP
3. Patient must have 100% chimerism with the donor
4. No recent donor lymphocyte infusion.
5. Patients must be able to sustain a platelet count and a hematocrit \> 20,000/mL and \> 27% respectively, with or without transfusions.
6. The absolute WBC must be \>1500/mL
7. Patient must be willing to comply with all study procedures.

Exclusion Criteria

1. Patients who are unable to tolerate the volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease, hepatorenal syndrome.
2. Active bleeding.
3. International normalized ration (INR) \>2.
4. Patients with known hypersensitivity or allergy to psoralen.
5. Patients with known hypersensitivity or allergy to both citrate and heparin.
6. Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.
7. Active, uncontrolled infection

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No