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NMDS Group

Sponsor : Nordic MDS group

Principal investigator:  Honar Cherif

Primary endpoints:  Safety and tolerability parameters including:

  • Clinical and laboratory Grade 3/Grade 4  non-hematologic toxicities related to study medication.
  • Increase in bone marrow and peripheral blood blast counts from baseline
  • AE, SAE and interactions at increasing doses of Eltrombopag treatment in combination with Azacitidine.

Status:  Final protocol 16/05/2011.

Start:  In Sweden only; October, 2011.

Research support:  GlaxoSmithKline

Inclusion criteria: 
Adult subjects (18 years of age or older) with advanced MDS or sAML/MDS requiring treatment with Azacitidine as approved by EMEA with platelet counts < 75 x 10(9)/L at start of Azacitidine treatment.

Exclusion criteria: 
According to protocol.

Treatment:  Oral Eltombopag in increasing doses for aproximately 13 weeks combined with Azacitidine

Contact person: Tobias Svensson, Honar Cherif, Uppsala

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