2022-502338-20-00招募中4 期
HU-F-AIM - A prospective, interventional study to evaluate HU-resistance in polycythemia vera patients who meet predictive parameters identified in the machine learning project PV-AIM
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 33
- 主要终点
- Proportion of PV patients with HU-resistance/intolerance within 6-9 months after start of de novo HU- treatment in presence of the PV-AIM HU-resistance predictors at the start of HU treatment.
研究概览
简要总结
Evaluation of HU-resistance/intolerance in PV patients who meet the predictive risk factors identified in the machine learning project PV-AIM (referred to as: PV-AIM HU-resistance predictors) at start of their regular HU-treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent must be obtained prior to participation in the study
- •Patients ≥ 18 years
- •Confirmed diagnosis of Polycythemia vera (according to WHO 2008, 2016, or 2022 criteria)
- •Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •No previous pharmacologic cytoreductive therapy (including investigational drugs)
- •No phlebotomy in last 14 days
- •HU-eligible • High-risk: age ≥ 60 years and/or prior history of thrombosis • Low-risk: showing at least one of the defined criteria o Signs of disease progression (myeloproliferation) o Increasing risk of thromboembolism and bleeding
- •Female participants of childbearing potential should have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study treatment.
排除标准
- •Patients with post- polycythemia vera myelofibrosis (post-PV MF) or accelerated phase/ blast phase myeloproliferative neoplasm acute myeloid leukemia (AP/BP-MPN AML)
- •Patients with a contraindication to HU according to the SmPC (severe bone marrow depression, leukopenia (< 2.5 x 10^9 leukocytes/l), thrombocytopenia (< 100 x 10^9 platelets/L), severe anemia (< 10 g/dL HGB)
- •Patients with rare hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption in their past medical history
- •Active uncontrolled infection that is considered by the Investigator as a reason for exclusion
- •Active malignancies (except for carcinoma in situ; prostate cancer and breast cancer in remission and – where necessary - ongoing hormonal therapy)
- •Inadequate renal function as demonstrated by Modification of Diet in Renal Disease estimate glomerular filtration rate (MDRDeGFR) < 30 mL/min/1.73m2 or on dialysis
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test.
- •Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 3 months after stopping study treatment.
- •HIV patients treated with nucleoside reverse transcriptase inhibitors like didanosine and stavudine
结局指标
主要结局
Proportion of PV patients with HU-resistance/intolerance within 6-9 months after start of de novo HU- treatment in presence of the PV-AIM HU-resistance predictors at the start of HU treatment.
Proportion of PV patients with HU-resistance/intolerance within 6-9 months after start of de novo HU- treatment in presence of the PV-AIM HU-resistance predictors at the start of HU treatment.
次要结局
- Proportion of PV patients who meet the PV-AIM HU-resistance predictors before start of HU-treatment
- Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months
- Proportion of patients developing HU resistance/intolerance at any time within the maximum treatment period of 15 months in presence or absence of the PV-AIM HU-resistance predictors at start of HU treatment.
- For all patients who develop HU resistance/intolerance according to (European LeukemiaNet) ELN criteria at any time during the maximum treatment period of 15 months • Proportion of “non-switchers” (i.e., patients remaining on HU despite they meet the HU-resistance/intolerance criteria) compared to “switchers” • Timepoint of therapy switch (after confirmation of HU resistance/intolerance) • Reasons for therapy switch / non-switch • Therapies applied during follow-up period
研究者
Medizinischer InfoService (MCC)
Scientific
Novartis Pharma GmbH
研究点 (33)
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