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

Therakos, Inc.0 个研究点目标入组 240 人开始时间: 2005年11月11日最近更新: 2013年4月22日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Therakos, Inc.
入组人数: 240

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Signed informed consent form.
•2. Patients must be greater than or equal to 18 years old and weigh equal to or more than 40 kg (88 lb).
•3. Patients must have received an allogenic hematopoietic bone marrow transplant (BMT) or peripheral blood stem cell transplant (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 allogenic hematopoietic BMT or PBSCT from a related or unrelated donor which is HLA-matched (6/6) (for HLA matches A, B, and DR).
•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 or 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 partner is of childbearing potential, she must have a negative urine 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 precautions throughout their participation in the study and for at least 3 months following their last ECP treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

排除标准

•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 less than 1.5 x 10 power9/L (1,500/microlitre).
•5. Patients who have a platelet count less than 20.0 x 10 power9/L (20,000/ microlitre), despite platelet transfusion.
•6. Patients whose 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 unable to tolerate the extracorporeal volume shifts associated with extracorporeal photoimmune therapy (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 less than 8.5 g/dL or male patients whose Hgb is less than 10.0 g/dL at screening, despite packed red blood cell transfusion.
•11. Patients who have a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
•12. Patients who have a known hypersensitivity or allergy to psoralen (methoxsalen).
•13. Patients who have a known hypersensitivity or allergy to both heparin and citrate products.
•14. Female patients who are pregnant or lactating.
•15. Patients who have co-existing melanoma, basal cell or squamous cell skin carcinoma, aphakia, photosensitive disease (e.g. porphyria, systemic lupus erythematosus, or albinism), white blood cell count greater than 25,000 cells/cubic millimetre, previous splenectomy, or coagulation disorders.

研究者

发起方

Therakos, Inc.

相似试验

进行中（未招募）

不适用

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 DiseaseGraft-versus-Host Disease

EUCTR2004-003774-29-GBTherakos, Inc.240

进行中（未招募）

1 期

EUCTR2004-003774-29-DETherakos, Inc.240

进行中（未招募）

不适用

EUCTR2004-003774-29-BETherakos, Inc.240

进行中（未招募）

不适用

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 - Acute GvHD-1

EUCTR2004-003774-29-ITTHERAKOS240

进行中（未招募）

不适用

A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High Grade Malignant Glioma - ASPECTOperable primary glioblastomaMedDRA version: 7.0Level: PTClassification code 10018338

EUCTR2004-000464-28-CZArk Therapeutics Limited250