JPRN-jRCT2031210007进行中（未招募）1 期
[M20-247] A Phase 1b Study of ABBV-744 Alone or in Combination with Ruxolitinib or Navitoclax in Subjects with Myelofibrosis
Okubo Sumiko0 个研究点目标入组 130 人开始时间: 2021年4月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Laboratory values indicative of adequate bone marrow, renal, and hepatic function meeting protocol criteria.
- •- Completion of the Myelofibrosis System Assessment Form (MFSAF) on at least 4 out of the 7 days prior to Day 1 with at least 2 symptoms with a score >=3 or a total score of >=10.
- •- Documented diagnosis of intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera MF (PPV-MF) or post-essential thrombocytopenia MF (PET-MF) as defined by the World Health Organization(WHO).
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- •- Intermediate - 2, or High-Risk disease as defined by the Dynamic International Prognostic Scoring System (For Segment A only, Intermediate - 1 with palpable splenomegaly >=5 centimeters [cm] below costal margin are also eligible).
- •- Splenomegaly defined as spleen palpation measurement >= 5 cm below costal margin or spleen volume >= 450 cubic cms as assessed by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan (for Segments A and c, baseline spleen assessment must be obtained > 7 days after discontinuation of most recent Myelofibrosis (MF) therapy. If possible, this assessment should occur within 10 days of Cycle 1 Day 1).
- •Segment-Specific Prior Therapy Criteria:
- •- Segment A:
- •--Prior exposure to one or more Janus Kinase inhibitors (JAKi), the most recent of which was discontinued > 28 days prior to Cycle 1, Day 1, and are intolerant, resistant, refractory or lost response to the JAKi.
- •- Segment B:
- •--Currently receiving ruxolitinib AND
- •--Willingness to reduce dose (if on a higher dose); and on a stable dose for 14 days or longer prior to Cycle 1 Day 1;
- •--At least one of the following criteria (a, b, or c):
- •a) >= 24 weeks duration of current ruxolitinib course, with evidence of disease that is resistant, refractory, or has lost response to ruxolitinib monotherapy;
- •b) < 24 weeks duration of current ruxolitinib course with documented resistance, refractories, or loss of response, as defined by any of the following:
- •---Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM), in
- •participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
- •--- >=100% increase in the palpable distance below the LCM, in participants with measurable spleen distance 5 -10 cm prior to the initiation of ruxolitinib.
- •--- >=50% increase in the palpable distance below the LCM, in participants with measurable spleen > 10 cm prior to the initiation of ruxolitinib.
- •---A spleen volume increase >= 25% (as assessed by MRI or CT) in participants with a spleen volume assessment available prior to the initiation of ruxolitinib.
- •c) Prior treatment with ruxolitinib for >= 28 days complicated by any of the following:
- •---Development of red blood cell transfusion requirement (at least 2 units/month for 2 months).
- •---Grade >= 3 adverse events of neutropenia and/or anemia while on ruxolitinib treatment, with improvement or resolution upon dose reduction.
- •- Segment C:
- •--Prior exposure to one or more JAKi (the most recent of which was discontinued > 28 days prior to Cycle 1 Day 1), and are intolerant, resistant, refractory or lost response to the JAKi.
排除标准
- •Segment-Specific Prior Therapy Criteria:
- •- Segment A:
- •--Prior exposure to one or more Bromodomain and Extra-Terminal (BET) inhibitors.
- •- Segment B:
- •--Prior exposure to one or more BET inhibitors.
- •- Segment C:
- •--Prior exposure to one or more BET inhibitors and/or any B-Cell Lymphoma 2 (BCL-2) and/or BCL- XL inhibitor, including navitoclax.
- •- Segment D:
- •--Prior exposure to JAKi and/or any BET inhibitor.
研究者
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