Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD)

NCT01140984 | Terminated

• 1 other identifier: MYS-08-HMO-CTIL
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Post allogeneic hematopoietic stem cell transplantation (HSCT) patients with steroid resistant acute GVHD localised to the liver will receive 24 hours continuous intra-arterial infusion of methylprednisolone.

Conditions

Acute Graft Versus Host Disease

Keywords

acute graft versus host disease; intra arterial steroid infusion; steroid resistant acute hepatic graft versus host disease

Outcome Measures

Primary Outcomes (1)

• Hepatic response

  The degree to which serum bilirubin levels do or do not decrease

  180 days

Study Arms (1)

treatment

EXPERIMENTAL

Drug: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)

Interventions

Methylprednisolone (Intra-arterial continuous infusion of corticosteroids) DRUG

Sedation/anesthesia of patient followed by placement of a 4F vascular sheath and a diagnostic and hepatic angiogram. Angiographic catheter tip to be placed in the proximal proper hepatic artery, secured in place externally and connected to an arterial line pressurized system which allows continuous drip infusion of methylprednisolone diluted in normal saline (600mg/m2 with maximal total dose of 100mg diluted in 480cc in normal saline administered at 20cc/hr for 24 hours).

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient of allogeneic stem cell transplantation.
• Age\>18 years.
• Post stem cells transplant \<100 days.
• AGVHD of liver, IBMTR index B, C, D.
• Has received no 1st line treatment for steroid refractory AGVHD.
• Signed a written informed consent

You may not qualify if:

• Active life-threatening infection.
• Inability to comply with study requirements.
• Inability to give informed consent.
• Contraindication to arterial catheterization (uncorrectable coagulopathy, severe allergic reaction to contrast material or others).
• An IBMTR index ≤ A.
• Refractory skin AGVHD or severe diarrhea..
• Pregnant or breast-feeding female or childbearing potential.
• Known to be HIV positive.
• Has been diagnosed with veno-occlusive disease.
• Has been diagnosed with multi organ failure.
• Known renal failure eGFR \<30

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organisation

Jerusalem, 91120, Israel

Location

Related Publications (14)

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  PMID: 9172802 BACKGROUND

• Brandenburg U, Gottlieb D, Bradstock K. Antileukemic effects of rapid cyclosporin withdrawal in patients with relapsed chronic myeloid leukemia after allogeneic bone marrow transplantation. Leuk Lymphoma. 1998 Nov;31(5-6):545-50. doi: 10.3109/10428199809057613.

  PMID: 9922044 BACKGROUND

• Graziani F, Van Lint MT, Dominietto A, Raiola AM, Di Grazia C, Lamparelli T, Gualandi F, Bregante S, Fiorone M, Bruno B, Bacigalupo A. Treatment of acute graft versus host disease with low dose-alternate day anti-thymocyte globulin. Haematologica. 2002 Sep;87(9):973-8.

  PMID: 12217810 BACKGROUND

• MacMillan ML, Weisdorf DJ, Davies SM, DeFor TE, Burns LJ, Ramsay NK, Wagner JE, Blazar BR. Early antithymocyte globulin therapy improves survival in patients with steroid-resistant acute graft-versus-host disease. Biol Blood Marrow Transplant. 2002;8(1):40-6. doi: 10.1053/bbmt.2002.v8.pm11858189.

  PMID: 11858189 BACKGROUND

• Tagliabue A, Corti P, Vigano E, Bonanomi S, Uderzo C. Favourable response to antithymocyte globulin therapy in resistant acute graft-versus-host disease. Bone Marrow Transplant. 2005 Sep;36(5):459. doi: 10.1038/sj.bmt.1705065. No abstract available.

  PMID: 15980883 BACKGROUND

• Arai S, Margolis J, Zahurak M, Anders V, Vogelsang GB. Poor outcome in steroid-refractory graft-versus-host disease with antithymocyte globulin treatment. Biol Blood Marrow Transplant. 2002;8(3):155-60. doi: 10.1053/bbmt.2002.v8.pm11939605.

  PMID: 11939605 BACKGROUND

• Khoury H, Kashyap A, Adkins DR, Brown RA, Miller G, Vij R, Westervelt P, Trinkaus K, Goodnough LT, Hayashi RJ, Parker P, Forman SJ, DiPersio JF. Treatment of steroid-resistant acute graft-versus-host disease with anti-thymocyte globulin. Bone Marrow Transplant. 2001 May;27(10):1059-64. doi: 10.1038/sj.bmt.1703032.

  PMID: 11438821 BACKGROUND

• Roy J, McGlave PB, Filipovich AH, Miller WJ, Blazar BR, Ramsay NK, Kersey JH, Weisdorf DJ. Acute graft-versus-host disease following unrelated donor marrow transplantation: failure of conventional therapy. Bone Marrow Transplant. 1992 Jul;10(1):77-82.

  PMID: 1515883 BACKGROUND

• Weisdorf D, Haake R, Blazar B, Miller W, McGlave P, Ramsay N, Kersey J, Filipovich A. Treatment of moderate/severe acute graft-versus-host disease after allogeneic bone marrow transplantation: an analysis of clinical risk features and outcome. Blood. 1990 Feb 15;75(4):1024-30.

  PMID: 2302454 BACKGROUND

• Martin PJ, Schoch G, Fisher L, Byers V, Appelbaum FR, McDonald GB, Storb R, Hansen JA. A retrospective analysis of therapy for acute graft-versus-host disease: secondary treatment. Blood. 1991 Apr 15;77(8):1821-8.

  PMID: 2015405 BACKGROUND

• Bloom AI, Shapira MY, Or R, Sasson T, Resnick IB, Zilberman I, Verstandig A, Aker M, Slavin S, Muszkat M. Intrahepatic arterial administration of low-dose methotrexate in patients with severe hepatic graft-versus-host disease: an open-label, uncontrolled trial. Clin Ther. 2004 Mar;26(3):407-14. doi: 10.1016/s0149-2918(04)90036-7.

  PMID: 15110133 BACKGROUND

• Sato T, Sakamaki S, Nagaoka Y, Kuribayashi K, Nagamachi Y, Morii K, Honma H, Kogawa K, Kato J, Niitsu Y. Intra-mesenteric artery steroid administration relieved severe refractory gastro-intestinal graft-vs.-host disease in an allogeneic bone marrow transplantation patient. Am J Hematol. 1997 Dec;56(4):277-80. doi: 10.1002/(sici)1096-8652(199712)56:43.0.co;2-6.

  PMID: 9395192 BACKGROUND

• Nakai K, Tajima K, Tanigawa N, Matsumoto N, Zen K, Nomura S, Fujimoto M, Kishimoto Y, Amakawa R, Sawada S, Fukuhara S. Intra-arterial steroid-injection therapy for steroid-refractory acute graft-versus-host disease with the evaluation of angiography. Bone Marrow Transplant. 2004 Jun;33(12):1231-3. doi: 10.1038/sj.bmt.1704523.

  PMID: 15094752 BACKGROUND

MeSH Terms

Interventions

Methylprednisolone

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2011-02

Locations

IL (1)