A phase II study of ruxolitinib (INCB018424) to evaluate efficacy and safety in Patients with Proliferative Chronic Myelomonocytic Leukemia (CMML) - RUXO_LMMC-PRO_1401

Grupo Español de Sindromes Mielodisplásicos (GESMD)0 sitesFebruary 7, 2014

Overview

No summary available.

Registry

who.int

Start Date

February 7, 2014

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Grupo Español de Sindromes Mielodisplásicos (GESMD)

•?Proliferative CMML according to French\-American\-British (FAB) diagnostic criteria.
•?Proliferative CMML patients with CMML\-specific prognostic scoring system (CPSS) low risk or intermediate 1; or intermediate\-2 or high who are not transplant candidates.
•?Patients must have a palpable spleen measuring 5 cm or greater from the costal margin to the point of greatest splenic. If not, a 15 cm or greater measured by ultrasonography.
•?To understand and voluntarily sign an informed consent form.
•?Age ?18 years at the time of signing the informed consent form.
•?Be able to adhere to the study visit schedule and other protocol requirements.
•?All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study. Patients carrying a somatic mutation involving the platelet derived growth factor beta (PDGF?) can be included if standard treatment with imatinib failed.
•?ECOG performance status of ?2 at study entry
•?Laboratory tests results within these ranges:
•\-Creatinine clearance \>30 mL/min.

•?Patients with inadequate bone marrow reserve as demonstrated by:
•\-Absolute neutrophil count (ANC) that is ? 1000/?L.
•\-Platelet count that is \<50,000/?L without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
•?Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
•?Patient transplant candidates with CMML specific prognostic scoring system (CPSS) intermediate 2 or high risk.
•?Pregnant or breast feeding females (lactating females must agree not to breast feed while taking INC424\).
•?Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•?To use any other experimental drug or therapy within 28 days of baseline.
•?Any prior use of INC424
•?Concurrent use of other anti\-cancer agents or treatments.