scholarly journals Randomized Double-Blind Clinical Trial Comparing Clobetasol and Dexamethasone for the Topical Treatment of Symptomatic Oral Chronic Graft-Versus-Host Disease

2014 ◽  
Vol 20 (8) ◽  
pp. 1163-1168 ◽  
Author(s):  
Cesar W. Noce ◽  
Alessandra Gomes ◽  
Vanessa Shcaira ◽  
Maria Elvira P. Corrêa ◽  
Maria Cláudia R. Moreira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Graft Versus Host Disease ◽  
Topical Treatment ◽  
Double Blind ◽  
Host Disease ◽  
Graft Versus Host ◽  
Double Blind Clinical Trial

Dramatic Increase of Tacrolimus Plasma Concentration During Topical Treatment for Oral Graft-Versus-Host Disease

2006 ◽  
Vol 82 (8) ◽  
pp. 1113-1115 ◽  
Author(s):  
Davide Conrotto ◽  
Marco Carrozzo ◽  
Ape Valeria Ubertalli ◽  
Sergio Gandolfo ◽  
Luisa Giaccone ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Graft Versus Host Disease ◽  
Topical Treatment ◽  
Host Disease ◽  
Graft Versus Host

scholarly journals Topical Corticosteroids a Viable Solution for Oral Graft versus Host Disease? A Systematic Insight on Randomized Clinical Trials

Medicina ◽  
2020 ◽  
Vol 56 (7) ◽  
pp. 349
Author(s):  
Arin Sava ◽  
Andra Piciu ◽  
Sergiu Pasca ◽  
Alexandru Mester ◽  
Ciprian Tomuleasa
Keyword(s):  
Clinical Trials ◽  
Graft Versus Host Disease ◽  
Randomized Clinical Trials ◽  
Open Label ◽  
Double Blind ◽  
Host Disease ◽  
Graft Versus Host ◽  
Overall Response ◽  
Topical Corticosteroids ◽  
Oral Gvhd

Background and Objectives: This research attempts to provide a clear view of the literature on randomized clinical trials (RCTs) concerning the efficacy of topical dexamethasone, clobetasol and budesonide in oral graft versus host disease (GVHD). Materials and Methods: An electronic search of the PubMed, Web of Science and Scopus databases was carried out for eligible RCTs. Studies were included if they had adult patients with oral GVHD treatment with topical corticosteroids, and if the RCT study was published in English. The Cochrane Risk of Bias tool was used to assess the quality of these studies. Overall, three RCTs were included (an Open, Randomized, Multicenter Trial; a Randomized Double-Blind Clinical Trial; and an Open-Label Phase II Randomized Trial). Results: The trials involved 76 patients, of which 44 patients received topical dexamethasone, 14 patients received topical clobetasol and 18 patients received topical budesonide. Topical agents were most frequently used when oral tissues were the sole site of involvement. It appears that the best overall response is present for budesonide with no difference between the four arms, followed by clobetasol, and then by dexamethasone. The limitation of the current study is mainly represented by the fact that overall response was derived in two of the studies from other parameters. Moreover, both budesonide and clobetasol were used in only one study each, while two assessed dexamethasone. Conclusions: Based on the clinical trials, all three agents seem to be effective in treating oral GVHD and had a satisfactory safety profile. There is still a need for assessing high quality RCTs to assess the efficacy of these therapies on a larger cohort.

Interleukin-1 blockade does not prevent acute graft-versus-host disease: results of a randomized, double-blind, placebo-controlled trial of interleukin-1 receptor antagonist in allogeneic bone marrow transplantation

Blood ◽  
2002 ◽  
Vol 100 (10) ◽  
pp. 3479-3482 ◽  
Author(s):  
Joseph H. Antin ◽  
Daniel Weisdorf ◽  
Donna Neuberg ◽  
Roberta Nicklow ◽  
Shawn Clouthier ◽  
...  
Keyword(s):  
Stem Cell ◽  
T Cell ◽  
Receptor Antagonist ◽  
Graft Versus Host Disease ◽  
Interleukin 1 ◽  
Double Blind ◽  
Host Disease ◽  
Double Blind Placebo ◽  
Graft Versus Host ◽  
Acute Graft

Acute graft-versus-host disease (GVHD) is thought to derive from direct T-cell injury of target tissues through perforin/granzyme, Fas/FasL interactions, and the effects of inflammatory cytokines. Animal models and some clinical trials support the notion that inhibition of inflammatory mediators such as interleukin-1 (IL-1), tumor necrosis factor α, and interferon γ may ameliorate or prevent GVHD. We hypothesized that blockade of IL-1 during the period of initial T-cell activation would reduce the risk of severe GVHD. We tested this hypothesis in a double-blind, placebo-controlled randomized trial of recombinant human IL-1 receptor antagonist (IL-1Ra) in 186 patients undergoing allogeneic stem cell transplantation. Randomization was stratified by degree of histocompatibility and stem cell source. All patients were conditioned with cyclophosphamide and total body irradiation. GVHD prevention consisted of cyclosporine and methotrexate in all patients. Recombinant human IL-1Ra or saline placebo was given from day −4 to day +10. Randomization was stratified according to GVHD risk. The 2 groups were well-matched for pretreatment characteristics. Moderate to severe GVHD (grades B-D) developed in 57 (61%) of 94 patients receiving IL-1Ra and in 51 (59%) of 86 patients on placebo (P = .88). There was no difference in hematologic recovery, transplantation-related toxicity, event-free survival, or overall survival. We conclude that blockade of IL-1 using IL-1Ra during conditioning and 10 days immediately after transplantation is not sufficient to reduce GVHD or toxicity or to improve survival.

A randomized, double-blind phase III study of ibrutinib versus placebo in combination with corticosteroids in patients with new onset chronic graft versus host disease.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS7072-TPS7072 ◽  
Author(s):  
David Bernard Miklos ◽  
Madan H. Jagasia ◽  
Hildegard Greinix ◽  
Bor-Sheng Ko ◽  
David A. Jacobsohn ◽  
...  
Keyword(s):  
Graft Versus Host Disease ◽  
Response Rate ◽  
Systemic Treatment ◽  
Underlying Disease ◽  
Development Project ◽  
Phase Iii ◽  
Consensus Development ◽  
Double Blind ◽  
Host Disease ◽  
Graft Versus Host

TPS7072 Background: Chronic graft versus host disease (cGVHD) is a common complication of allogeneic stem cell transplantation, with pathophysiology involving alloreactive and dysregulated T and B cells and innate immune populations. Ibrutinib, a first-in-class, once-daily inhibitor of Bruton's tyrosine kinase, is indicated by the US FDA for the treatment of patients (pts) with CLL/SLL. Ibrutinib recently received breakthrough therapy and orphan drug designation for the treatment of pts with cGVHD who did not respond to one or more lines of systemic therapy. Ibrutinib reduces severity of cGVHD in murine models and recently was shown to achieve an NIH-defined overall response rate of 67% in pts with steroid relapsed/refractory cGVHD (Miklos Blood 2016). Methods: The primary objective of this Phase 3, multicenter, international, randomized, controlled, double-blind study is to evaluate the 24-week response rate of ibrutinib versus placebo in combination with prednisone. Pts with newly diagnosed moderate or severe cGVHD, as per NIH Consensus Development Project Criteria (2014), will be randomized in a 1:1 ratio to receive either oral ibrutinib (arm A) or placebo (arm B) in combination with oral prednisone. Ibrutinib or placebo will be given until unacceptable toxicity, relapse of underlying disease, death, or the need for a new systemic treatment for progressive cGVHD. Eligible study pts (age ≥12 yrs) must require systemic treatment with corticosteroids and have no prior systemic treatment for cGVHD. The primary endpoint is response rate (complete or partial response) at 24 weeks, as per NIH Consensus Development Project Criteria, and must occur in the absence of both new therapy for cGVHD and relapse/return of the underlying disease that was the indication for transplant. Secondary endpoints will assess for additional clinical benefit including corticosteroid dose reduction, improvement of Lee cGVHD Symptom Scale scores, withdrawal of all immunosuppressants, and overall survival. This study is currently enrolling pts. Funding source: Pharmacyclics LLC, an AbbVie Company. Clinical trial information: NCT02959944.

scholarly journals Phase I Clinical Trial Evaluating Abatacept in Patients with Steroid-Refractory Chronic Graft Versus Host Disease

2017 ◽  
Vol 23 (3) ◽  
pp. S376
Author(s):  
Myrna R. Nahas ◽  
Robert J. Soiffer ◽  
Edwin P. Alyea ◽  
Jon E. Arnason ◽  
Robin Joyce ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Graft Versus Host Disease ◽  
Phase I Clinical Trial ◽  
Host Disease ◽  
Graft Versus Host ◽  
Steroid Refractory

scholarly journals Initial Results of KD025-208: A Phase 2a Open-Label Clinical Trial of KD025 for Steroid-Dependent Chronic Graft Versus Host Disease (cGVHD)

2018 ◽  
Vol 24 (3) ◽  
pp. S70 ◽  
Author(s):  
Aleksandr Lazaryan ◽  
Stephanie J. Lee ◽  
Amandeep Salhotra ◽  
Madan Jagasia ◽  
James H. Essell ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Graft Versus Host Disease ◽  
Open Label ◽  
Host Disease ◽  
Graft Versus Host ◽  
Steroid Dependent ◽  
Initial Results

Double blind clinical trial of the Ageratina pichinchensis extract in the topical treatment of onychomycosis

Planta Medica ◽  
2012 ◽  
Vol 78 (11) ◽  
Author(s):  
O Romero-Cerecero ◽  
A Zamilpa ◽  
JE Jiménez-Ferrer ◽  
J Tortoriello ◽  
J Tortoriello
Keyword(s):  
Clinical Trial ◽  
Topical Treatment ◽  
Double Blind ◽  
Double Blind Clinical Trial

scholarly journals Prospective, Randomized, Double-Blind, Phase III Clinical Trial of Anti–T-Lymphocyte Globulin to Assess Impact on Chronic Graft-Versus-Host Disease–Free Survival in Patients Undergoing HLA-Matched Unrelated Myeloablative Hematopoietic Cell Transplantation

2017 ◽  
Vol 35 (36) ◽  
pp. 4003-4011 ◽  
Author(s):  
Robert J. Soiffer ◽  
Haesook T. Kim ◽  
Joseph McGuirk ◽  
Mitchell E. Horwitz ◽  
Laura Johnston ◽  
...  
Keyword(s):  
Cell Transplantation ◽  
T Lymphocyte ◽  
Graft Versus Host Disease ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Phase Iii ◽  
Double Blind ◽  
Free Survival ◽  
Host Disease ◽  
Graft Versus Host

Purpose Several open-label randomized studies have suggested that in vivo T-cell depletion with anti–T-lymphocyte globulin (ATLG; formerly antithymocyte globulin-Fresenius) reduces chronic graft-versus-host disease (cGVHD) without compromising survival. We report a prospective, double-blind phase III trial to investigate the effect of ATLG (Neovii Biotech, Lexington, MA) on cGVHD-free survival. Patients and Methods Two hundred fifty-four patients 18 to 65 years of age with acute leukemia or myelodysplastic syndrome who underwent myeloablative HLA-matched unrelated hematopoietic cell transplantation (HCT) were randomly assigned one to one to placebo (n =128 placebo) or ATLG (n = 126) treatment at 27 sites. Patients received either ATLG or placebo 20 mg/kg per day on days −3, −2, −1 in addition to tacrolimus and methotrexate as GVHD prophylaxis. The primary study end point was moderate-severe cGVHD-free survival. Results Despite a reduction in grade 2 to 4 acute GVHD (23% v 40%; P = .004) and moderate-severe cGVHD (12% v 33%; P < .001) in ATLG recipients, no difference in moderate-severe cGVHD-free survival between ATLG and placebo was found (2-year estimate: 48% v 44%, respectively; P = .47). Both progression-free survival (PFS) and overall survival (OS) were lower with ATLG (2-year estimate: 47% v 65% [ P = .04] and 59% v 74% [ P = .034], respectively). Multivariable analysis confirmed that ATLG was associated with inferior PFS (hazard ratio, 1.55; 95% CI, 1.05 to 2.28; P = .026) and OS (hazard ratio, 1.74; 95% CI, 1.12 to 2.71; P = .01). Conclusion In this prospective, randomized, double-blind trial of ATLG in unrelated myeloablative HCT, the incorporation of ATLG did not improve moderate-severe cGVHD-free survival. Moderate-severe cGVHD was significantly lower with ATLG, but PFS and OS also were lower. Additional analyses are needed to understand the appropriate role for ATLG in HCT.

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