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ClinicalTrials.gov

To search for all NIH clinical trials re: chronic GVHD, visit ClinicalTrials.gov

  1. Enter “Chronic GVHD” or “GVHD” in the Search for Clinical Trials textbox.
  2. Click the Search button.

Featured Clinical Trials: Chronic GVHD

Below are brief summaries of current cGVHD clinical trials submitted by members of the NIH cGVHD Study Group. All cGVHD members are encouraged to submit their trial summaries. All featured trials must first be listed in ClinicalTrials.gov and be open for recruitment.

To submit a summary of your current cGVHD clinical trial, contact Dr. Steven Pavletic.

Evaluation of Efficacy and Mechanism of Topical Thalidomide for Chronic Graft-Versus-Host Disease Related Stomatitis (NINR, PI: Jane Fall-Dickson, PhD, RN)
This is a phase II, eight-week study investigating the efficacy and safety of topical thalidomide gel for treatment of chronic graft-versus-host disease related oral mucositis and associated oral pain. Patients must have at least one oral ulcer in order to be eligible to participate. Patients will be randomized to receive either topical thalidomide 20mg gel or placebo which is self-applied four times daily for 4 weeks. Subjects will be evaluated weekly and then at 8 weeks. Saliva, blood, and oral ulcer exudates will be collected weekly and then at 8 weeks. A small punch biopsy of the oral mucosa near the ulcer site will be done at week 1 and at week 4. Quality of life questionnaire will be administered at week 1 and week 4. The study is also being conducted at the Fred Hutchinson Cancer Research Center, Seattle, WA. PIs: Mark M. Schubert, DDS, MS, and Mary E. Flowers, MD

Prospective Assessment of Clinical and Biological Factors Determining Outcomes in Patients With Chronic Graft-Versus-Host Disease (NCI, PI: Steven Pavletic, MD)
This is a natural history study. Patients referred for evaluation of chronic graft-vs-host disease (cGVHD) undergo a clinical and laboratory multispecialty diagnostic evaluation that includes blood collection and biopsies. A summary of the multidisciplinary evaluation and recommendations are conveyed to the patient and primary physician. Selected clinical outcomes data is collected from patients by telephone and mail (i.e., interviews and questionnaires) every 6 months for 3 years and then annually for up to 10 years.

Pilot Study of Topical Dexamethasone 0.01% Solution for Prevention of Oral Chronic Graft Versus Host Disease (NHLBI, PI: Dawn Arrington, MD)
Prevention of oral GVHD by topical agents is an attractive strategy because it would potentially avoid the adverse effects associated with systemic immunosuppression. Consenting subjects who have undergone hematopoietic stem cell transplantation at the NIH Clinical Center will be randomized to receive dexamethasone 0.01% solution or placebo as an oral rinse for 3 months starting 90-100 days post-transplant. Subjects will be evaluated monthly after the start of intervention. The primary objective of the study is to determine if the topical use of dexamethasone 0.01% solution will significantly decrease the incidence of symptomatic oral graft versus host disease.

Treatment of Chronic Graft Versus Host Disease With Extracorporeal Photopheresis (NIAID, PI: Harry Malech, MD)
This is a phase 2 study of extracorporeal photopheresis (ECP) for treatment of chronic graft versus host disease following allogeneic hematopoietic stem cell transplantation. Eligible patients must have objective evidence of chronic graft versus host disease that is refractory to conventional therapy or must have steroid-dependent disease that does not permit steroid dose reduction. The primary objective of this study is to better define the safety, efficacy and mechanism of action of ECP for treatment of patients with chronic graft versus host disease.