EUCTR2020-001989-10-HU进行中（未招募）1 期
A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients - Phase 3 Study of CPI-0610 in MF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 310
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
- •Patients are eligible to be included in the study only if all of the following criteria apply:
- •1. = 18 years of age at the time of signing the informed consent
- •Type of Patient and Disease Characteristics
- •2. Have a confirmed diagnosis of MF (PMF or PPV-MF or PET-MF) in accordance with the 2016 WHO criteria (Section 10.4)
- •3. Require therapy for MF in the opinion of the Investigator and are eligible for treatment with ruxolitinib
- •4. Have DIPSS risk category Intermediate-1 or higher (Section 10.5)
- •5. Have spleen volume of = 450 cm3 by MRI or CT scan (either local or central read)
- •6. Have completed the MFSAF v4.0 (Section 10.6) at least 5 of 7 days prior to randomization
- •7. Have at least 2 symptoms with an average score = 3 over the 7-day period prior to randomization or an average total score of = 10 over the 7-day period prior to randomization using the MFSAF v4.0 (Section 10.6)
- •8. Have acceptable laboratory assessments obtained within 28 days prior to the first dose of study medication:
- •ANC = 1 × 109/L in the absence of growth factors or transfusions for the previous 4 weeks
- •Platelet count = 100 × 109/L in the absence of growth factors or transfusions for the previous 4 weeks
- •Peripheral blood blast count < 5%
- •AST and ALT = 2.5 × ULN (= 5 × if the elevation can be ascribed to liver involvement; e.g., presence of hepatomegaly)
- •Serum direct bilirubin < 2.0 × ULN
- •Calculated or measured CrCl of = 45 mL/min
- •9. ECOG performance status of = 2
- •10. Life expectancy > 24 weeks per Investigator assessment
- •11. Have fully recovered from major surgery, intervention, and from the residual Grade 1 toxicity from prior MF-specific therapy (grade 1 peripheral neuropathy and alopecia are allowed).
- •12. Male and female patients with reproductive potential must agree to use highly effective contraceptive methods (i.e., condoms or sexual abstinence if the preferred and usual lifestyle of the patient for males and oral, intravaginal, transdermal inhibitors of ovulation that contain estrogen and progesterone; oral, injectable or implantable inhibitors of ovulation that contain progesterone; IUD; IUS; bilateral tubal occlusion; vasectomized partner; sexual abstinence if the preferred and usual lifestyle of the patient for females) while on study therapy and for 3 months after the last dose of study drug. NOTE: Male patients should be informed of the risk of testicular toxicity and provided with adequate advice regarding sperm preservation.
- •Informed Consent
- •13. Capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- •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 155
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 155
排除标准
- •1. Had splenic irradiation within 6 months of starting study drug
- •2. Had prior splenectomy
- •3. Are a candidate for, and willing to undergo allogeneic HSCT, and, in the opinion of the Investigator, the benefit of proceeding to an allogeneic HSCT prior to treatment with a JAK2 inhibitor outweighs its risks
- •4. Have current known active or chronic infection with HIV, hepatitis B, or hepatitis C. Screening of patients with serologic testing for these viruses is not required. However, patients who have a past history of viral hepatitis or in whom there is a current suspicion of viral hepatitis should have serologic testing for hepatitis B and hepatitis C performed to determine whether there is any current evidence for ongoing infection with these viruses. Patients considered to be at risk for HIV infection should have HIV testing performed.
- •5. Have an active infection. Patients will not be eligible for enrollment until recovery to = Grade 1 for at least 2 weeks prior to the first dose of study drug.
- •6. Have impaired gastrointestinal function or gastrointestinal disease, including active IBD, that could significantly alter the absorption of study drug, including any unresolved nausea, vomiting, or diarrhea > Grade 1
- •7. Have known hypersensitivity to the investigational agent or ruxolitinib, or its metabolites or formulation excipients
- •8. Have a history of progressive multifocal leukoencephalopathy
- •9. Have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- •Acute myocardial infarction or unstable angina pectoris = 6 months prior to starting study drug
- •QTcF > 500 msec on the screening ECG
- •New York Heart Association Class III or IV congestive heart failure
- •Uncontrolled clinically significant cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
- •-Patients with a history of coronary artery disease and revascularization are not excluded.
- •10. Have ongoing uncontrolled hypertension (resting systolic blood pressure >160 mmHg and resting diastolic blood pressure >100 mmHg) despite maximal treatment with at least 2 anti-hypertensive agents
- •11. Have ongoing uncontrolled blood glucose increase (HbA1c =9%) despite maximal treatment with oral and/or injectable anti-hyperglycemic agents
- •12. Have a history of a concurrent or second malignancy except for adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, 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, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for = 3 years
- •13. Have any other concurrent severe and/or uncontrolled concomitant medical condition which acc. to the Investigator could compromise participation in the study or analysis of study data. This includes but is not limited to clinically significant pulmonary disease or neurological disorders.
- •14. Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm
- •15. Had systemic anti-cancer treatment other than hydroxyurea and anagrelide less than 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug. NOTE: Hydroxyurea and anagrelide are permitted up to 24 hours prior
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