EUCTR2017-001541-26-Outside-EU/EEA进行中（未招募）1 期
A Study of Venetoclax in Combination With Navitoclax and Chemotherapy in Subjects With Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AbbVie Inc
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
- •nclusion Criteria:
- •a) Must have relapsed or refractory acute lymphoblastic leukemia (ALL) or relapsed or refractory lymphoblastic lymphoma (LL). Refractory is defined as persistent disease after at least 2 courses of chemotherapy.
- •- Participants with ALL with Philadelphia chromosome or with an ABL class targetable fusion are eligible.
- •- Participants with LL must have radiographic evidence of disease
- •b) Participants <= 18 years of age who do not have a standard of care treatment option available.
- •c) Must weigh greater than or equal to 20 kg.
- •d) Must be able to swallow pills.
- •e) Must have adequate hepatic and kidney function.
- •f) Must have adequate performance status:
- •- Participants less than or equal to 16 years of age: Lansky greater than or equal to 50
- •- Participants greater than 16 years of age: Karnofsky greater than or equal to 50 or Eastern Cooperative Oncology Group (ECOG) less than 3.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •a) Participant has central nervous system (CNS) disease with cranial involvement that requires radiation.
- •b) Participants who are less than 100 days post-transplant, or greater than 100 days post-transplant with active graft versus host disease (GVHD), or are still continuing post-transplant immunosuppressant therapy within 7 days prior to the first dose of study drug.
- •c) Participants who have received any of the following prior to the first dose of study drug:
- •- Inotuzumab within 30 days (if participant received inotuzumab > 30 days prior to Day 1, must have ALT, AST and bilirubin < ULN).
- •- A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent within 30 days
- •- CAR-T infusion or other cellular therapy within 30 days
- •- Any anti-cancer therapy including blinatumomab, chemotherapy, radiation therapy targeted small molecule agents or investigational agents within 14 days, or 5 half-lives, whichever is shorter
- •d) Exception: Philadelphia Chromosome (Ph)+ ALL subjects on TKIs at Screening may enroll and remain on Tyrosine Kinase Inhibitor (TKI) therapy to control disease. Participants on venetoclax at screening may enroll and remain on venetoclax.
- •- Steroid therapy for anti-neoplastic intent within 5 days
- •- Hydroxyurea that is ongoing (hydroxyurea is permitted up to the first dose)
- •- A strong or moderate CYP3A inhibitor or inducer within 7 days
- •- Aspirin within 7 days, or 5 half-lives, whichever is longer
- •- An excluded antiplatelet/anticoagulant drug or a herbal supplement that affects platelet function within 7 days, or 5 half-lives, whichever is longer
- •e) Participants with malabsorption syndrome or any other condition that precludes enteral administration
研究者
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