European Leukemia Trial Registry
Trial: BUM-5/GVH

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Public Title Efficacy and Safety Study of Budesonide to Treat Oral Chronic GvHD
Scientific Title Double-blind, Randomised, Placebo-controlled Multicentre Phase III Clinical Study Followed by Open-label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic GvHD
Short Title BUM-5/GVH
Id KN/ELN LN_NN_2009_503
Trialgroup NN
Type of Trial multicentric, randomized, prospective, double-blind, double-group
Phase Phase III
Disease Miscellaneous(Miscellaneous) Supportive Care
Stage of Disease not specified / all stages
Inclusion Criteria
  • Karnofsky >= 70
  • Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation
  • Oral cGvHD of erosive and/or ulcerative type
  • NIH scale >= 3
  • Resistant oral cGvHD with no oral response to conventional primary treatment
Exclusion Criteria
  • Uncertain diagnosis of resistant oral cGvHD
  • Symptomatic oral cGvHD of hyperkeratotic type solely
  • Current active oral bacterial, viral, or fungal infection
  • Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain
  • Requiring addition of new systemic therapy including steroids, or radiation therapy
  • Local intestinal infection
  • Abnormal hepatic function or liver cirrhosis
  • If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection
  • Second line treatment of oral cGvHD with topical steroids
Age <= 75 years
Status No longer recruiting
Start of Recruitment 01.04.2009
Recruiting Countries Germany
Israel
Target Sample Size 225
Leader Wolff, Prof. Dr., Daniel
Shortprotocol Shortprotocol
Sponsors Dr. Falk Pharma GmbH (Main Sponsor)
Other Registers ClinicalTrials.gov NCT00887263 (primary Register)
European Clinical Trials Database - EUDRACT 2008-004562-10
Outcomes
  • Rate of patients with objective response [12 weeks] (Primary Outcome)
  • Rate of complete/partial response, stable disease, progressive disease [12 weeks]
  • Time to initial objective response
  • Rate of subjective improvement [12 weeks]
created 01.10.2012 Sina Hehn
changed 20.03.2015 Hanna Ebert
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