A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Ster… (NCT02340676) | Clinical Trial Compass
CompletedPhase 2
A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD
United States25 participantsStarted 2015-02
Plain-language summary
This research study is evaluating a combination of a therapy called Extra-corporeal Photopheresis (ECP) with a drug called Interleukin-2 (IL-2) as a possible treatment for chronic graft-versus-host-disease (GVHD) following allogeneic stem cell transplant.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Recipients of 7-8/8 HLA matched adult donor allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens.
* Participants must have steroid-refractory cGVHD. Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD (Appendix D; section 17.4) despite the use of prednisone at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms. Patients with either extensive chronic GVHD or limited chronic GVHD requiring systemic therapy are eligible.
* Stable dose of corticosteroids for 4 weeks prior to enrollment
* No addition or subtraction of other immunosuppressive medications (e.g., calcineurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrollment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug
* Patient age ≥18 years old. Because no dosing or adverse event data are currently available on the use of IL-2 in participants \<18 years of age, children are excluded from this study.
* Estimated life expectancy greater than 3 months.
* ECOG performance status 0-2 (Appendix A; section 17.1).
* Participants must have adequate organ function as defined below:
* Hepatic: Adequate hepatic function (total …
What they're measuring
1
Percentage of Participant With Response at Week 16