Graft-versus-Host Disease
Conditions
Interventions
Trade Name: Uvadex 20 micrograms/ml. Solution for blood fraction modification.
Product Name: UVADEX
Product Code: UVADEX
Pharmaceutical Form: Solution for blood fraction modification
INN or Proposed I
Sponsors
Therakos, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy of Extra-Corporeal Therapy (ECP) treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute Graft-versus-Host disease (GvHD) (Grades II to III) that developed with 100 days following an allogeneic hematopoietic progenitor cell transplant.;Secondary Objective: ;Primary end point(s): The primary efficacy variable in the study is complete resolution of acute GvHD, defined as less than Grade 1 acute GvHD, according to the Glucksberg-Seattle criteria. Treatment success for the purposes of the primary efficacy endpoint is defined as complete resolution at Weeks 4 and 8. That is, a patient is a treatment success if he/she experiences a complete resolution of acute GvHD at Week 4 and remains free of the disease through Week 8. The following will be considered treatment failures for the purposes of the primary endpoint: 1. Patients who die or discontinue study treatment because of GvHD. 2. Patients who receive second-line therapy for GvHD at any time through Week 8. 3. Patients who receive greater than 2.5 mg/kg/day of a methylprednisolone equivalent at any time through Week 8. The treatment arms will be compared with respect to the proportion of patients with treatment success, using the normal approximation of the binomial distribution. In addition, a 95% confidence interval will be provided for the difference between the treatment arms in the proportion of patients with a treatment success. | — |
Countries
Austria, Belgium, Germany, Italy, United Kingdom
Outcome results
None listed