Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved IL-2 for the treatment of chronic GVHD but it has been approved for metastatic renal cell carcinoma (MCC) and metastatic melanoma. ECP is a standard of care treatment for chronic GVHD that has not responded to steroids. Chronic GVHD is a medical condition that may occur after receiving bone marrow, stem cell or cord blood transplant from a donor. The donor's immune system may recognize (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host disease. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Participants on this trial have not responded to steroid therapy. The investigstors are looking to assess whether the combination of IL-2 and ECP therapy helps control chronic GVHD by stopping the donor's immune system from 'rejecting' the participant's body. Participants will receive standard-of-care ECP treatment two times a week for 16 weeks. Each treatment will last approximately 2-3 hours. Starting after Week 8 of the ECP treatments, participants will give themselves or be given IL-2 through an injection under their skin. Participants will do this once every day for 8 weeks until the end of the 16-week ECP treatment. If a participant's GVHD worsens during the initial 8 weeks of ECP treatment, he or she has the option of starting IL-2 early. If a participant's chronic GVHD improves at the end of the 16-week study duration, he or she may have the option of continuing the combination therapy of ECP and IL-2. Extended duration therapy is twice weekly ECP treatments plus daily IL-2 starting at the end of week 16. Participants may also have the option of continuing ECP treatments without IL-2 after the end of Week 16. If this is the case, participants will only be followed for one year from the start of therapy and will not have required study visits or tests. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02340676
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 2015
Completion date December 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04189432 - Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease Phase 2
Terminated NCT03557749 - Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
Completed NCT05121142 - Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease Phase 1
Recruiting NCT04202835 - ATG Plus PTCy vs ATG for CGVHD Prophylaxis Phase 2
Terminated NCT03640481 - Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy Phase 2
Completed NCT01036958 - Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease
Recruiting NCT04372524 - Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
Active, not recruiting NCT03604692 - A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD Phase 1/Phase 2
Recruiting NCT05355675 - The Association of Microbiota Composition With cGVHD After Allo-HSCT
Active, not recruiting NCT04710576 - A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD) Phase 2
Terminated NCT04200365 - A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD) Phase 2
Not yet recruiting NCT06263478 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease Phase 3
Not yet recruiting NCT06388564 - A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease Phase 2
Terminated NCT02123966 - An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease Phase 2
Recruiting NCT05692713 - Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)
Terminated NCT04446182 - Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD Phase 2
Active, not recruiting NCT05305989 - Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213 Phase 2
Completed NCT04540133 - Dexamethasone Solution and Dexamethasone in Mucolox™ Phase 2
Not yet recruiting NCT03190733 - A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT Phase 4
Active, not recruiting NCT04716075 - Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT) Phase 2