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POMINC

AcronymISRCTNEudraCTClinicaltrials.govDRKS
MPNSG01-122012-002431-29

A Phase-Ib/II Study of Ruxolitinib and Pomalidomide Combination Therapy in Patients with Primary and Secondary Myelofibrosis

Status: Active

Purpose / Objectives

Primary Outcome

  • To evaluate the clinical efficacy of ruxolitinib and pomalidomide combination therapy in primary and secondary MF patients

Secondary Outcomes

  • To evaluate progression-free survival, response duration and overall survival
  • To assess quality of life

Diagnosis

Adult patients with diagnosis of Myeloproliferative Neoplasms (MPN) either de novo myelofibrosis (PMF), secondary myelofibrosis (post-PV MF and post-ET MF) who have either received prior treatment or never received treatment.

Patient attributes

Age

18-99

Inclusion criteria

  • Both female and male patients meeting the mentioned inclusion and exclusion criteria will be included in this clinical trial. The risk to get PMF or SMF does not depend on a patient’s gender. Patients must meet ALL of the following inclusion criteria to be eligible for enrollment into the study:
  • Age18 years at the time of voluntarily signing an IRB/IEC-approved informed consent
  • Diagnosis of Myeloproliferative Neoplasms (MPN) either de novo myelofibrosis according to 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.
  • Reliable contraception should be maintained throughout the study and for 28 days after study treatment discontinuation
  • Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods
  • Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP. 
     
    All subjects must:
    • understand that the investigational product could have a potential teratogenic risk.
  • be counseled about pregnancy precautions and risks of fetal exposure.
  • agree to abstain from donating blood while taking investigational.                            

Exclusion criteria

  • Pregnant or breast feeding females
  • BCR/ABL-positivity
  • Diagnosis of ET (according to WHO 2008 criteria)
  • Diagnosis of PV (according to WHO 2008 criteria)
  • >20% blasts in peripheral blood or bone marrow
  • thrombocytopenia <100 /nl or transfusion-dependent thrombocytopenia
  • neutropenia <0.5 /nl
  • Known positive status for HIV, HBV or HCV
  • Prior treatment with IMiDs (thalidomide, lenalidomide) or with Interferonalpha within a 3 month time period before Screening-phase
  • History of thrombosis or pulmonary embolism within 6 months prior to study entry
  • Peripheral neuropathy >grade 1 CTC
  • No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
  • Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
  • Drug or alcohol abuse within the last 6 months
  • Patients with other malignancy either in the medical history or currently active other than non-melanoma skin cancers.
  • Patients undergoing treatment with hematopoietic growth factor receptor agonists (i.e., erythropoietin [Epo], granulocyte colony stimulating factor (GCSF [Neupogen; Neulasta], romiplostim, eltrombopag) within a 4 weeks period prior to screening-phase.
  • Patients receiving any medication listed in the Appendix V “Prohibited Medications” (within 7 days prior to the first dose of study drug).
  • Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.
  • Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 28 days of screening.

Trial design

  • Phase I/II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Intervention

  • Ruxolitinib 10mg BID
  • Pomalidomide 0,5mg QD

Both for 12 Cycles á 28 days.

Miscellaneous

- Treatment until progression or withdrawal;

- further treatment after 12 cycles if patient has benefit.

Documents (password protected)

Responsibilities in overall trial

Universitätsklinikum Ulm AÖR

  • Tel. +49 (0)731-5000

National Coordinating Investigator

Prof. Konstanze Döhner

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active

Principal Investigator

Prof. Dr. med. Dr. h. c. Christoph Scheid

Deputy of Principal Investigator

  • PD Dr. Dr. med. Udo Holtick

Subinvestigator

  • Dr. med. Anke Burst, geb. Krause (inaktiv)
  • Prof. Dr. med. Jens-Markus Chemnitz (inaktiv)
  • Dr. med. Maximilian Fresen
  • PD Dr. med. Stephanie Sasse

Contact at Site