EUCTR2012-002431-29-DE进行中（未招募）1 期
A Phase-Ib/II Study of Ruxolitinib and Pomalidomide Combination Therapy in Patients with Primary and Secondary Myelofibrosis - POMINC
niversity Hospital of Ulm0 个研究点目标入组 90 人开始时间: 2013年3月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age =18 years at the time of voluntarily signing an IRB/IEC-approved informed consent
- •2. 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)
- •3. Anemia with hemoglobin level of <10 g/dl or transfusion-dependent anemia
- •4. Splenomegaly (>11 cm total diameter) and/or leukoerythroblastosis
- •5. 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
- •6. Subject must be willing to receive transfusion of blood products
- •7. ECOG performance status <3
- •8. Females of childbearing potential (FCBP) must undergo repetitive pregnancy testing (serum or urine) and pregnancy results must be negative.
- •9. Reliable contraception should be maintained throughout the study and for 28 days after study treatment discontinuation
- •10. Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods
- •11. Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP. Males must agree not to donate semen or sperm
- •12. All subjects must:
- •-understand that the investigational product (in particular Pomalidomide) could have a potential teratogenic risk.
- •-be regulary counseled about pregnancy precautions and risks of fetal exposure.
- •-agree to abstain from donating blood while receiving investigational product during dose interruptions and for at least 28 days after last dose.
- •agree not to share study medication with another person and to return all unused study drug to the investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •1. Patients eligible for hematopoietic stem cell transplantation (suitable candidate and suitable donor is available)
- •2. Patients with response to standard therapy as recommended by the Deutsche Gesellschaft für Hämatologie und Medizinische Onkologie (DGHO/Onkopedia)
- •3. Pregnant or breast feeding females
- •4. BCR/ABL-positivity
- •5. Diagnosis of ET (according to WHO 2016 criteria)
- •6. Diagnosis of PV (according to WHO 2016 criteria)
- •7. >20% blasts in peripheral blood or bone marrow
- •8. thrombocytopenia <100 /nl or transfusion-dependent thrombocytopenia
- •9. neutropenia <0.5 /nl
- •10. Known positive status for HIV, HBV or HCV
- •11. Prior treatment with IMiDs (thalidomide, lenalidomide, pomalidomide) or with Interferon-alpha within a 3 month time period before Screening-phase
- •12. Patient treatment with Ruxolitinib within a 14 days time period before Screening-phase
- •13. History of thrombosis or pulmonary embolism within 6 months prior to study entry
- •14. Peripheral neuropathy >grade 1 CTC
- •15. 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.
- •16. 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
- •17. Drug or alcohol abuse within the last 6 months
- •18. History of malignancy except for i) adequately treated local basal cell or squamous cell carcinoma of the skin, ii) asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for = 1 year prior to randomization, or iii) any other cancer that has been in complete remission for = 5 years
- •19. 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.
- •20. Patients receiving any medication listed in the Appendix V Prohibited Medications” (within 7 days prior to the first dose of study drug).
- •21. 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.
- •22. Patients under ongoing treatment with another investigational medication or having been treated with an investigational medication within 28 days of screening.
- •23. No consent for biobanking.
- •24. Patients who cannot adhere to Pregnancy Prevention Plan
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