A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy with UVADEXTM for the Treatment of Patients with Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

Study ID
STU 052011-003

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital– Zale Lipshy
  • UT Southwestern University Hospital—St. Paul

Contact
Joyce Bolluyt
214-648-7007
joyce.bolluyt@utsouthwestern.edu

Principal Investigator
Madhuri Vusirikala

Summary

Patients who meet the entry criteria will be randomized 1:1 to receive 26 weeks of standard of care treatment and follow-up visits at 2- or 4-week intervals for 30 weeks. Long-term follow-up will subsequently be obtained every 6 months for a total of 2 years study participation.

Patients should have a baseline visit performed within 4 days of the initiation of corticosteroids and will receive one of two treatments:

1- Standard of Care Control Arm
Initiate corticosteroids at prednisone equivalent of 1.0 mg/kg daily.

Initiate/continue CsA agent at usual prescribed dose to maintain appropriate serum level (maintain a cyclosporine level of 100-175 mg/mL or a tacrolimus level of 7-10 ng/mL).

2- Standard of Care plus ECP Arm
Initiate corticosteroids at prednisone equivalent of 1.0 mg/kg daily.

Initiate/continue CsA agent at usual prescribed dose to maintain appropriate serum level (maintain a cyclosporine level of 100-175 mg/mL or a tacrolimis level of 7-10 ng/mL). Patients randomized to the ECP arm must receive their first ECP treatment within 5 days of baseline visit

The frequency of ECP treatments will be :
Week 1: 3 treatments in the first 7 days.
Weeks 2-10: 2 treatments per week.
Weeks 11-18: 2 treatments per week every 2 weeks.
Weeks 19-26: 2 treatments per week every 4 weeks.

A framework for a steroid tapering algorithm will be applied to each patient in both treatment arms.

Patients with new onset cGvHD who meet the NIH Consensus Criteria for moderate or severe cGvHD and require systemic therapy can enroll into the study. The investigator will not be blinded but a third party blinded observer at each site will assess the condition of each patient at appropriate visits using the NIH Clinical forms and will also complete a TSS for those patients with cutaneous involvement. The blinded will be provided the appropriate
laboratory data (blood test results, pulmonary function tests PFTs, etc) in a blinded manner to assist in the determination of NIH Consensus Response Criteria.

Participant Eligibility

1. Are able to provide written informed consent.
2. Patients with new onset moderate or severe cGvHD per the NIH Consensus Criteria* (for staging and severity) definition as assessed by the NIH Consensus Criteria Clinical Assessment* (NIH Clinical Assessment *Forms and instructions are provided in Study Reference Manual) with onset within 2 years of transplantation.
3. Patients with prior acute GvHD symptoms should be on a stable dose of <0.5 mg/kg daily prednisone, or equivalent, for at least 2 weeks prior to study entry. Prior ECP for acute GvHD is permitted in the study.
4. Age ≥18 years.
5. Weight >40 kg.
6. Platelet count >25,000/μL (including platelet support).
7. Eastern Cooperative Oncology Group (ECOG) score of 0-2 (see Appendix 2).
8. Life expectancy of at least 3 months with no imminent relapse expected.
9. Women of childbearing potential and all men must be using adequate birth control measures (e.g., abstinence, oral contraceptive, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the study.
10. Women with childbearing potential must provide a negative pregnancy test within
10 days before study start.
11. Patients must be able and willing to comply with all study procedures.