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

This study has been terminated.
(Lack of recruitment)
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by:
Therakos
ClinicalTrials.gov Identifier:
NCT00282503
First received: January 24, 2006
Last updated: June 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Acute Graft-versus-Host Disease
Drug: Methoxsalen+ECP, Methylprednisolone
Procedure: Ecp
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Therakos:

Primary Outcome Measures:
  • To compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    The primary efficacy analysis will be performed on the primary endpoint. The primary efficacy variable in this study is complete resolution of acute GvHD, defined as less than Grade I acute GvHD, according to the Glucksberg-Seattle criteria.


Enrollment: 19
Study Start Date: January 2006
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: methylprednisolone equivalent.
2mg/kg daily will be administered initially and may be tapered according to a tapering schedule provided in the protocol.
Drug: Methoxsalen+ECP, Methylprednisolone

Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:

  • Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
  • Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be > 4 days between the ECP treatments within a week.)

Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions:

Daily Dose (mg/kg)

1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10

Other Name: Uvadex+ ECP
Experimental: Uvadex+ECP

Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:

  • Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
  • Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days
Drug: Methoxsalen+ECP, Methylprednisolone

Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:

  • Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
  • Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be > 4 days between the ECP treatments within a week.)

Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions:

Daily Dose (mg/kg)

1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10

Other Name: Uvadex+ ECP
Procedure: Ecp
ECP or Extra Corporeal Phototherapy will be used with UVADex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 Oxsoralen (methoxsalen).
  13. Patients who have a known hypersensitivity or allergy to both heparin and citrate products.
  14. Female patients who are pregnant and/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 > 25,000 cells/mm3, previous splenectomy, or coagulation disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282503

  Show 35 Study Locations
Sponsors and Collaborators
Therakos
PRA Health Sciences
Investigators
Study Director: Dennis Parenti, MD Therakos
  More Information

No publications provided

Responsible Party: Dennis Parenti, Therakos
ClinicalTrials.gov Identifier: NCT00282503     History of Changes
Other Study ID Numbers: Acute GvHD-1
Study First Received: January 24, 2006
Last Updated: June 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Therakos:
aGvHD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Methoxsalen
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014