National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group Report

Martin, Paul J.; Weisdorf, Daniel J.; Przepiorka, Donna; Hirschfeld, Steven; Farrell, Ann T.; Rizzo, J. Douglas; Foley, Ronan; Socié, Gèrard; Carter, Shelly; Couriel, Daniel; Schultz, Kirk R.; Flowers, Mary E.D.; Filipovich, Alexandra H.; Saliba, Rima M.; Vogelsang, Georgia B.; Pavletić, Steven Z.; Lee, Stephanie J.

doi:10.1016/j.bbmt.2006.03.004

Cited by 160 publications

(127 citation statements)

References 13 publications

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“…The diagnosis and grading of acute and chronic GvHD was assigned by the transplant center using standard criteria. 21,22 Statistical analysis Median values and ranges were used for continuous variables and percentages for categorical variables (Table 1). For each continuous variable, the study population was initially split into quartiles and in two groups by the median.…”

Section: Endpointsmentioning

confidence: 99%

Impact of pretransplant minimal residual disease after cord blood transplantation for childhood acute lymphoblastic leukemia in remission: an Eurocord, PDWP–EBMT analysis

et al. 2012

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To address the prognostic value of minimal residual disease (MRD) before unrelated cord blood transplantation (UCBT) in children with acute lymphoblastic leukemia (ALL), we analyzed 170 ALL children transplanted in complete remission (CR) after myeloablative conditioning regimen. In all, 72 (43%) were in first CR (CR1), 77 (45%) in second CR (CR2) and 21 (12%) in third CR (CR3). The median interval from MRD quantification to UCBT was 18 days. All patients received single-unit UCBT. Median follow-up was 4 years. Cumulative incidence (CI) of day-60 neutrophil engraftment was 85%. CI of 4 years relapse was 30%, incidence being lower in patients with negative MRD before UCBT (hazard ratio (HR) ¼ 0.4, P ¼ 0.01) and for those transplanted in CR1 and CR2 (HR ¼ 0.3, P ¼ 0.002). Probability of 4 years leukemia-free survival (LFS) was 44%, (56, 44 and 14% for patients transplanted in CR1, CR2 and CR3, respectively (P ¼ 0.0001)). Patients with negative MRD before UCBT had better LFS after UCBT compared with those with positive MRD (54% vs 29%; HR ¼ 2, P ¼ 0.003). MRD assessment before UCBT for children with ALL in remission allows identifying patients at higher risk of relapse after transplantation. Approaches that may decrease relapse incidence in children given UCBT with positive MRD should be investigated to improve final outcomes.

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Section: Endpointsmentioning

confidence: 99%

Impact of pretransplant minimal residual disease after cord blood transplantation for childhood acute lymphoblastic leukemia in remission: an Eurocord, PDWP–EBMT analysis

et al. 2012

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“…Desta maneira, um grupo de trabalho do National Institutes of Health (NIH) desenvolveu um projeto para consenso dos critérios que deverão ser utilizados em estudos clínicos da DECH-c, [8][9][10][11][12][13] padronizou as características utilizadas no diagnóstico e propôs meios para a pontuação dos órgãos envolvidos e avaliação global da gravidade. 8 Estes critérios são úteis para uma melhor análise da incidência da DECH-c, além de poder avaliar a gravidade do comprometimento de um órgão, ou local, isolado, ou combinado, e a influência na mortalidade tardia do transplante.…”

Section: Critérios Para O Diagnóstico E Classificação Da Doença Enxerunclassified

Diretrizes para o diagnóstico, classificação, profilaxia e tratamento da doença enxerto contra hospedeiro crônica

Bouzas¹,

Silva²,

Tavares³

et al. 2010

Rev. Bras. Hematol. Hemoter.

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“…It is suggested that progression of cGVHD despite 1 mg/kg/day of corticosteroids for 2 weeks or lack of improvement in symptoms after 4-8 weeks of continuous therapy or inability to taper corticosteroids should be considered as refractory disease [121]. The endpoints for the treatment of cGVHD is subjective and some of the effects of cGVHD are irreversible.…”

Section: Second-line Treatment Of Cgvhdmentioning

confidence: 99%

State-of-the-art acute and chronic GVHD treatment

Jamil

Mineishi

2015

Int J Hematol

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owing to the advancement in reduced intensity conditioning (RIC) and in patients without HLA-matched donors due to the use of cord blood and haploidentical HSCT [4][5][6]. Although marked improvement has been made in supportive care, immunosuppressive therapy and DNA-based Human Leukocyte Antigen (HLA) typing, graft vs host disease (GVHD) remains a major cause of morbidity and non-relapse mortality among allogeneic HSCT recipients. It was first described by Billingham in 1966 as a syndrome where immunocompetent T cells from the donor recognize and damage the host tissue in an immunocompromised recipient. It presents with heterogeneous symptoms involving multiple organ systems including gastrointestinal tract, skin, mucosa, liver and lungs [7]. In the past clinical features occurring within 100 days after HSCT was called acute GVHD (aGVHD) and those happening after 100 days were labeled chronic GVHD (cGVHD) [8,9]. This definition was rather unsatisfactory thus National Institute of Health (NIH) consensus criteria were developed and have been revised. The criteria have added new categories such as late-onset aGVHD (acute GVHD occurring after 100 days) and overlap syndrome which includes features of both acute and chronic GVHD to the classification, and also have introduced new definitions for organ system involvement [10][11][12]. The categorization of acute vs chronic GVHD is based on the combination of clinical symptoms rather than the time of onset. Depending upon a number of variables associated with patients, donors, and types of transplant, the incidence of aGVHD varies with incidence of grade II-IV GVHD at 40 % in matched related donor (MRD) transplant to 50 % in MUD transplant. The main risk factors for aGVHD include degree of HLA mismatch, age of the patient, previous all immunization of the donor and the kind of GVHD prophylaxis used. About 30-70 % of allogeneic HSCT recipients alive after 100 days will Abstract Graft-versus-host disease (GVHD) remains as the major obstacle for successful hematopoietic stem cell transplant (HSCT). Roughly half of the patients undergoing HSCT develop GVHD which requires treatment, and above 10 % of the patient may die because of it. However, GVHD presents with anti-tumor activity, called graft-versus-tumor (GVT) effect, and it carries significant anti-tumor activity, thus suppressing GVHD completely may increase the relapse of original disease. Thus, it is important to control GVHD to the appropriate level.

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National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group Report

Cited by 160 publications

References 13 publications

Impact of pretransplant minimal residual disease after cord blood transplantation for childhood acute lymphoblastic leukemia in remission: an Eurocord, PDWP–EBMT analysis

Impact of pretransplant minimal residual disease after cord blood transplantation for childhood acute lymphoblastic leukemia in remission: an Eurocord, PDWP–EBMT analysis

Diretrizes para o diagnóstico, classificação, profilaxia e tratamento da doença enxerto contra hospedeiro crônica

State-of-the-art acute and chronic GVHD treatment

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