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Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease

A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease

NCT00282503•Mallinckrodt

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent must be obtained prior to conducting any study procedure.
•2. Patients must be greater than or equal to 18 years old and weigh greater than or equal to 40 kg (88 lb).
•3. Patients must have received an allogeneic hematopoietic BMT or PBSCT with myeloablative or reduced-intensity conditioning and have a new onset of acute GvHD, Grades II to III, which includes the skin and developed within 100 days following an allo-HPCT.
•4. Patients must have received an allogeneic hematopoietic BMT or PBSCT from a related or unrelated donor that is matched at a minimum at the HLA-A, -B, and -DR loci (i.e., at least a 6 out of 6 match). HLA-A and -B match should be determined by serologic testing, and HLA-DR should be matched by molecular methods.
•5. Patients must be receiving only a calcineurin inhibitor at study entry as part of their acute GvHD prophylactic regimen. Patients may have received additional immunosuppressants for acute GvHD prophylaxis prior to study entry.
•6. Patients must have a Karnofsky performance greater than or equal to 50.
•7. Patients must be able and willing to comply with all study procedures.
•8. Patients must receive, or must have received, the first corticosteroid dose of approximately 2.0 mg/kg/day but no more than 2.5 mg/kg/day (methylprednisolone equivalent) within 24 hours of the initial diagnosis of Grade II to III acute GvHD. (Up to 2.5 mg/kg/day is allowed for inadvertent dosing fluctuations for reasons other than lack of response.)
•9. Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening. Male patients must also commit to using adequate contraceptive precautions (condoms). All patients (both males and females of childbearing potential) must commit to using adequate contraceptive precautions throughout their participation in the study and for at least 3 months following their last ECP treatment.

Exclusion Criteria

•1. Patients who have been diagnosed with chronic GvHD, including de novo chronic GvHD, prior to 100 days following an allo-HPCT.
•2. Patients who have received donor lymphocyte infusions.
•3. Patients with uncontrolled life-threatening infections.
•4. Patients who have a white blood cell (WBC) count \< 1.5 x 10\^9/L (1,500/mcL).
•5. Patients who have a platelet count \< 20.0 x 10\^9/L (20,000/mcL), despite platelet transfusion.
•6. Patients whose total bilirubin is greater than or equal to 22 mg/dL.
•7. Patients who have an International Normalized Ratio (INR) greater than or equal to 2.
•8. Patients who are enrolled in any concomitant investigation for the treatment of acute GvHD.
•9. Patients who are unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, hepatic encephalopathy, or hepatorenal syndrome.
•10. Female patients whose hemoglobin (Hgb) is \< 8.5 g/dL or male patients whose Hgb is \< 10.0 g/dL at screening, despite packed red blood cell transfusion.
+5 more criteria

Locations (35)

University of Florida

Gainesville, Florida, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Weill Medical College of Cornell University

New York, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Leukemia and Bone Marrow Transplant Center - Avera Cancer Institute

Sioux Falls, South Dakota, United States

Royal Brisbane Women's Hospital

Brisbane, Australia

Saint Vincent's Hospital

Darlinghurst, Australia

Westmead Hospital

Westmead, Australia

Medical University of Vienna

Vienna, Austria

Universite Catholique De Louvain

Brussels, Belgium

Key Dates

Start Date

January 1, 2006

Primary Completion Date

June 1, 2007

Last Updated

August 16, 2017

Enrollment

ACTUAL participants

Conditions

Acute Graft-versus-Host Disease

Interventions

Methoxsalen+ECP, Methylprednisolone

DRUG

Ecp

PROCEDURE

A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.

NCT07070674

Acute Graft-versus-Host Disease

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RECRUITINGPHASE2

MAGIC Ruxolitinib for aGVHD

NCT06936566

Acute Graft-versus-host DiseaseAllogeneic Bone Marrow Transplantation+1 more

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 16, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease

Inclusion Criteria

Exclusion Criteria

A Phase Ib Clinical Study of AC-003 Capsules in Subjects With aGVHD.

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