Skin Disease and Pulmonary Mortality After Transplantation

NCT03320928 | Completed

• 1 other identifier: TIM Photochem 3
• Study Type: observational
• Target: 79
• Locations: 0 countries
• Sites: N/A

Brief Summary

Predictors for pulmonary mortality was determined in a cohort of 79 patients with acute-GVHD of the skin. The acute-GVHD treatment was corticosteroids and photochemotherapy (Photosensitization with oral 8-methoxysalen and Ultraviolet light type A) with or without concomitant methotrexate.

Conditions

Pulmonary Mortality; Acute GVH Disease

Outcome Measures

Primary Outcomes (1)

• Crude Pulmonary Mortality

  The Primary outcome; Crude pulmonary mortality was defined as lethal outcome of pulmonary disease and comprised IPS including interstitial pneumonitis with or without pulmonary infection, but also pneumonia and undefined respiratory insufficiency or interstitial fibrosis. As secondary outcome pulmonary mortality was divided into a binary variable; where those causes primarily associated with severe immunosuppression e.g. pulmonary mortality secondary to opportunistic infections; i.e. CMV-pneumonitis, fungal pneumonia or with a diagnosis of CMV-infection or fungal infections at the time of pulmonary mortality, was separated from the group of patients who died from pulmonary mortality without concomitant opportunistic disease. The cause of Death was derived from the Death certificate.

  10 years

Secondary Outcomes (3)

• Relapse

  10 years

• Survival

  10 years

• Complete response in acute-GVHD

  Two weeks after the end of treatment

Interventions

Photochemotherapy OTHER

Retrospective evaluation of treatment outcome and risk for pulmonary mortality and relapse incidence

Also known as: Methotrexate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Transplantation at Huddinge University Hospital (Karolinska UH) and treated with photochemotherapy at the Dermatology department before the end of 2005.

You may qualify if:

• \- Treatment with photochemotherapy for aGVHD of the skin at the Dermatology Department at Huddinge Hospital before the end of 2005.

You may not qualify if:

• \- Retransplantation or DLI before photochemotherapy

Sponsors & Collaborators

• Karolinska University Hospital: lead

Related Publications (10)

• Ringdén O, Deeg HJ. Clinical spectrum of graft-versus-host disease. In: Ferrara JL, Deeg HJ, Burakoff S (eds). Graft vs Host Disease, Second Edition. Marcel Dekker: New York, NY, US, 1996, pp 525 - 595.

  BACKGROUND

• Glucksberg H, Storb R, Fefer A, Buckner CD, Neiman PE, Clift RA, Lerner KG, Thomas ED. Clinical manifestations of graft-versus-host disease in human recipients of marrow from HL-A-matched sibling donors. Transplantation. 1974 Oct;18(4):295-304. doi: 10.1097/00007890-197410000-00001. No abstract available.

  PMID: 4153799 BACKGROUND

• Remberger M, Aschan J, Barkholt L, Tollemar J, Ringden O. Treatment of severe acute graft-versus-host disease with anti-thymocyte globulin. Clin Transplant. 2001 Jun;15(3):147-53. doi: 10.1034/j.1399-0012.2001.150301.x.

  PMID: 11389703 BACKGROUND

• Parrish JA, Fitzpatrick TB, Tanenbaum L, Pathak MA. Photochemotherapy of psoriasis with oral methoxsalen and longwave ultraviolet light. N Engl J Med. 1974 Dec 5;291(23):1207-11. doi: 10.1056/NEJM197412052912301. No abstract available.

  PMID: 4422691 BACKGROUND

• Henseler T, Wolff K, Honigsmann H, Christophers E. Oral 8-methoxypsoralen photochemotherapy of psoriasis. The European PUVA study: a cooperative study among 18 European centres. Lancet. 1981 Apr 18;1(8225):853-7. doi: 10.1016/s0140-6736(81)92137-1.

  PMID: 6112291 BACKGROUND

• Yanik G, Cooke KR. The lung as a target organ of graft-versus-host disease. Semin Hematol. 2006 Jan;43(1):42-52. doi: 10.1053/j.seminhematol.2005.09.004.

  PMID: 16412788 BACKGROUND

• Watkins TR, Chien JW, Crawford SW. Graft versus host-associated pulmonary disease and other idiopathic pulmonary complications after hematopoietic stem cell transplant. Semin Respir Crit Care Med. 2005 Oct;26(5):482-9. doi: 10.1055/s-2005-922031.

  PMID: 16267699 BACKGROUND

• Forslow U, Mattsson J, Ringden O, Klominek J, Remberger M. Decreasing mortality rate in early pneumonia following hematopoietic stem cell transplantation. Scand J Infect Dis. 2006;38(11-12):970-6. doi: 10.1080/00365540600786481.

  PMID: 17148063 BACKGROUND

• Bjorklund A, Aschan J, Labopin M, Remberger M, Ringden O, Winiarski J, Ljungman P. Risk factors for fatal infectious complications developing late after allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 Dec;40(11):1055-62. doi: 10.1038/sj.bmt.1705856. Epub 2007 Sep 24.

  PMID: 17891187 BACKGROUND

• Nassar A, Elgohary G, Elhassan T, Nurgat Z, Mohamed SY, Aljurf M. Methotrexate for the Treatment of Graft-versus-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation. J Transplant. 2014;2014:980301. doi: 10.1155/2014/980301. Epub 2014 Oct 27.

  PMID: 25405023 BACKGROUND

MeSH Terms

Interventions

Photochemotherapy; Methotrexate

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: October 25, 2017
• Study Start: October 21, 2016
• Primary Completion: November 24, 2016
• Study Completion: November 24, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share