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NMDS Group

 

Sponsor: Nordic MDS group

Project group:

Principal investigator: Dr Lars Möllgård (Sahlgrenska, Gothenburg)

Study committee: Lars Möllgård (Sahlgrenska, Gothenburg), Olle Werlenius (Sahlgrenska, Gothenburg), Johan Aurelius (Sahlgrenska Cancer Center, Gothenburg), Kristoffer Hellstrand (Sahlgrenska Cancer Center, Gothenburg), Eva Hellström Lindberg (Karolinska, Huddinge), Lars Nilsson (Skåne University Hospital, Lund), Mats Brune (Sahlgrenska, Gothenburg), Anna Martner (Sahlgrenska Cancer Center, Gothenburg) and Fredrik Bergh Thorén (Sahlgrenska Cancer Center, Gothenburg).

Immunological substudies: Johan Aurelius, Sahlgrenska Cancer Center, Gothenburg

Primary objective

  • To evaluate the safety and feasibility of treatment with HDC/IL-2 in CMML.

Secondary objectives

  • To evaluate the clinical efficacy of HDC/IL-2 treatment in CMML.
  • To investigate the immunological effects of HDC/IL-2 in CMML.

Status: Recruiting

Start: Q1 2017

Treatment: Enrolled subjects will receive histamine dihydrochloride (HDC; Ceplene®) and/or IL-2 (Proleukin®) subcutaneously (s.c.) twice daily (BID) in 3-week periods followed by 3- or 6 week rest periods.

Study population:

  • >=18 years of age at the time of signing the informed consent form.
  • CMML-1 with indication for treatment according to NMDSG guidelines.
  • Life expectancy of more than three months and ability to undergo routine outpatient evaluations for efficacy, safety, and compliance.
  • Informed consent obtained and signed.

Contact person: Lars Möllgård

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