A phase I clinical trial to study the safety of treatment with Tipifarnib (ZARNESTRA) combined with Bortezomib (VELCADE) in patients with myelodysplastic syndrome (MDS) - Bortezomib and Tipifarnib in MDS

niversitair Medisch Centrum Sint Radboud0 sites18 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

niversitair Medisch Centrum Sint Radboud

•MDS (including the non\-proliferative form of CMML, i.e. CMML with a WBC count \< 12,0 x 109\) /L with \< 30% blast cells in the bone marrow and with \< 5% circulating blasts).
•IPSS score: Intermediate Risk\-2 or High Risk
•Age at the time of obtaining informed consent 18 years or older
•WHO performance status 0\-2

•IPSS score: low risk and intermediate\-1 category.
•Candidates for allogeneic stem cell transplantation.
•Clinical relevant liver (AST/ALT equal to or higer than 1,5 ULN and bilirubin equal to or higher than 2 mg/dl) or renal insufficiency (ECC \< 50 %).
•Significant vascular, pulmonary, gastrointestinal, endocrine, rheumatologic, or metabolic disturbances.
•Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment.
•Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 8 weeks before enrollment.
•Having received a stem cell transplantation.