CTIS2023-509120-17-00招募中1 期
A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-risk Myelofibrosis (MF) Relapsed / Refractory (R/R) to Janus Kinase (JAK)-Inhibitor - GRN163LMYF3001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Geron Corp.
- 入组人数
- 354
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Diagnosis of PMF according to the revised WHO criteria (Section 18.2); or PET-MF or PPV-MF according to the IWG-MRT criteria (Section 18.3) confirmed by local pathology report., Dynamic International Prognostic Scoring System intermediate-2 or high-risk MF (Section 18.4)., Relapsed / Refractory to JAK-inhibitor treatment as defined in either inclusion 4.1, 4.2 or 4.3 and not eligible for ASCT at screening: 4.1: Treatment with JAK-inhibitor for = 6 months duration, including at least 2 months at an optimal dose as assessed by the investigator for that participant and at least ONE of the following: a) no decrease in spleen volume (< 10% by MRI or CT) from the start of treatment with JAK-inhibitor. b) no decrease in spleen size (< 30% by palpation or length by imaging) from start of treatment with JAK-inhibitor. c) no decrease in symptoms (< 20% by MFSAF or myeloproliferative neoplasm SAF) from start of treatment with JAK-inhibitor. d) a score of at least 15 on TSS assessed using the MFSAF v4.0 (adapted as the MF Symptom Recall Form, Section 18.6) during screening. 4.2: Treatment with JAK-inhibitor for = 3 months duration with maximal doses for that participant (e.g. 20-25 mg twice daily ruxolitinib) without a spleen or symptom response as defined in inclusion criterion 4.1 (a, b, or c) and would not benefit from remaining on treatment for 6 months. 4.3: Following maximum tolerated doses of JAK inhibitor therapy for =3 months duration, having documented relapsed disease defined as either: • Increase in spleen volume from time of best response by 25% measured by MRI or CT, or • Increase in spleen size by palpation, CT, or ultrasound - For splenomegaly of 5-10 cm at the start of JAK inhibitor treatment, at least 100% increase in palpable spleen size from time of best response; - For splenomegaly of > 10 cm at the start of JAK inhibitor treatment, at least 50% increase in palpable spleen size from time of best response; AND not a candidate for further JAK inhibitor at screening per investigator., Measurable splenomegaly demonstrated by a palpable spleen measuring = 5 cm below the left costal margin or a spleen volume = 450 cm3 by MRI or CT., Active symptoms of MF on the MFSAF v4.0 (adapted as the MF Symptom Recall Form, Section 18.6) demonstrated by a symptom score of at least 5 points (on a 0 to 10 scale) on at least 1 of the symptoms or a score of 3 or greater on at least 2 of the following symptoms: fatigue, night sweats, itchiness, abdominal discomfort, pain under ribs on left side, early satiety, and bone pain., Hematology laboratory test values within the following limits: • absolute neutrophil count (ANC) = 1.5 x 10^9/L independent of growth factor support, AND • platelets = 75 x 10^9/L independent of platelet transfusion support.
排除标准
- •Peripheral blood blast count of = 10% or bone marrow blast count of = 10%., Prior treatment with imetelstat., Any chemotherapy or MF directed therapy, including investigational drug regardless of class or mechanism of action, immunomodulatory or immunosuppressive therapy, corticosteroids > 30 mg/day prednisone or equivalent, and JAK-inhibitor treatment = 14 days prior to randomization., Diagnosis or treatment for malignancy other than MF except: - Malignancy treated with curative intent and with no known active disease present for = 3 years before randomization. - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. - Adequately treated cervical carcinoma in situ without evidence of disease., Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification., Known history of human immunodeficiency virus or any uncontrolled active systemic infection requiring IV antibiotics.
研究者
相似试验
进行中（未招募）
1 期
A study comparing current available therapies with imetelstat for the treatment of intermediate-2 or high-risk MF who are not responding to JAK-inhibitor treatmentMyelofibrosisEUCTR2020-003288-24-DKGeron Corporation320
进行中（未招募）
1 期
A study comparing current available therapies with imetelstat for the treatment of intermediate-2 or high-risk MF who are not responding to JAK-inhibitor treatmentMyelofibrosisEUCTR2020-003288-24-PTGeron Corporation320
进行中（未招募）
1 期
A study comparing current available therapies with imetelstat for the treatment of intermediate-2 or high-risk MF who are not responding to JAK-inhibitor treatmentMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MyelofibrosisEUCTR2020-003288-24-DEGeron Corporation320
进行中（未招募）
1 期
A study comparing current available therapies with imetelstat for the treatment of intermediate-2 or high-risk MF who are not responding to JAK-inhibitor treatmentMyelofibrosisEUCTR2020-003288-24-BEGeron Corporation320
进行中（未招募）
1 期
A study comparing current available therapies with imetelstat for the treatment of intermediate-2 or high-risk MF who are not responding to JAK-inhibitor treatmentMyelofibrosisEUCTR2020-003288-24-ATGeron Corporation320