Ruxolitinib and Pomalidomide Combination Therapy in Patients With Primary and Secondary MF (NCT01644110) | Clinical Trial Compass
CompletedPhase 1/2
Ruxolitinib and Pomalidomide Combination Therapy in Patients With Primary and Secondary MF
Germany96 participantsStarted 2013-08
Plain-language summary
The proposed study is an open-label, single-arm, Phase-Ib/II trial to assess the efficacy of oral drug combination ruxolitinib and pomalidomide in primary and secondary MF patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years at the time of voluntarily signing an IRB/IEC-approved informed consent
✓. Diagnosis of Myeloproliferative Neoplasms (MPN) either de novo myelofibrosis according to current WHO criteria (PMF), secondary myelofibrosis (post-PV MF and post-ET MF) according to the IWG-MRT consensus terminology) (Appendix I)
✓. Anemia with hemoglobin level of \<10 g/dl or transfusion-dependent anemia\*
✓. Splenomegaly (\>11 cm total diameter) and/or leukoerythroblastosis
✓. Adequate organ function, i.e. ALT and/or AST \<3 x upper limit of normal (ULN), total bilirubin \<3 x ULN, and serum creatinine \<2 mg/dl
✓. Subject must be willing to receive transfusion of blood products
✓. ECOG performance status \<3
✓. Females of childbearing potential (FCBP) must undergo repetitive pregnancy testing (serum or urine) and pregnancy results must be negative.\*\*
Exclusion criteria
✕. Patients eligible for hematopoietic stem cell transplantation (suitable candidate and suitable donor is available)
✕. Patients with response to standard therapy as recommended by the Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie (DGHO/Onkopedia)
✕. Pregnant or breast feeding females
✕
What they're measuring
1
Best response rate within 12 treatment cycles according to the IWG-MRT criteria (including CR, PR, CI) and red cell transfusion (RCT) independency according to Gale et al 2010 and 2011).