NL-OMON50711已完成3 期
A Randomized, Open-label, Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Patients With Relapsed or Refractory Mature B-cell non-Hodgkin Lymphoma. - 54179060LYM3003/Sparkle
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
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
- 2 至 99（—）
入选标准
- •- 1 to <18 years of age enrollment will begin with children in the 2 older age
- •groups (6-11, 12-17 years) to assess pharmacokinetics and safety data before
- •allowing enrollment of children in the youngest age group (1-5 years) (Part 1
- •only), or 1 to 30 years of age, inclusive, if initial diagnosis of mature
- •B-cell NHL occurred at <18 years of age (Part 2 only)
- •- Relapsed/refractory BL, Burkitt-like lymphoma (BLL), Burkitt leukemia (ie,
- •B-AL) with FAB3 morphology or presence of surface immunoglobulin by flow
- •cytometry, DLBCL, DLBCL not otherwise specified (NOS), or other pediatric
- •mature B-cell NHL
- •- Must be in first recurrence and have received only one prior line of therapy
- •or have disease that is primarily refractory to conventional therapy
- •- Must have at least 1 of the following:
- •a) 1 site of measurable disease >1 cm in the longest diameter and >1 cm in the
- •shortest diameter by radiological imaging
- •b) bone marrow involvement
- •c) cerebrospinal fluid with blasts present
- •- Lansky-Karnofsky score of *50
- •- Adequate organ function
- •- Must have recovered from the acute toxic effects of prior chemotherapy,
- •immunotherapy, or radiotherapy, in the opinion of the investigator, prior to
- •entering this study.
- •- signed, written, informed consent or assent as applicaple.
- •- Adolescents/young women of childbearing potential must be practicing a highly
- •effective method of contraception (failure rate of <1% per year when used
- •consistently and correctly) and agree to remain on a highly effective method
- •throughout the study and for at least 3 months after the last dose of ibrutinib
- •and 1 year after the last dose of the background CIT.
- •- Must be willing and able to adhere to the prohibitions and restrictions
- •specified in this protocol
排除标准
- •- Ongoing anticoagulation treatment with warfarin or equivalent vitamin K
- •antagonists (eg, phenprocoumon), or ongoing treatment with agents known to be
- •strong CYP3A4/5 inhibitors, or has taken any disallowed therapies, Prohibited
- •Medications, before the planned first dose of study drug
- •- Inherited or acquired bleeding disorders
- •- Clinically significant arrhythmias, complex congenital heart disease, or left
- •ventricular ejection fraction (LVEF) <50% or shortening fraction (SF) *28%
- •- Known history of human immunodeficiency virus (HIV) or active Hepatitis B or
- •- Any condition that could interfere with the absorption or metabolism of
- •ibrutinib including malabsorption syndrome, disease significantly affecting
- •gastrointestinal function, or resection of the stomach or small bowel
- •- Known allergies, hypersensitivity, or intolerance to ibrutinib or its
- •excipients (refer to Investigator's Brochure)
- •- Known allergy, hypersensitivity, or intolerance to any of the backbone CIT
- •- Received an investigational drug (including investigational vaccines) or used
- •an invasive investigational medical device within 30 days before the planned
- •first dose of study drug, or is - currently being treated in an investigational
- •- Pregnant, or breastfeeding, or planning to become pregnant while enrolled in
- •this study or within 3 months after the last dose of study drug
- •- Plans to father a child while enrolled in this study or within 3 months after
- •the last dose of study drug
- •- Any condition for which, in the opinion of the investigator, participation
- •would not be in the best interest of the subject (eg, compromise the
- •well-being) or that could prevent, limit, or confound the protocol-specified
- •assessments
- •- Had major surgery, (eg, requiring general anesthesia) within 4 weeks before
- •enrollment/randomization, or has not fully recovered from surgery, or has
- •surgery planned during the time the subject is expected to participate in the
- •study or within 4 weeks after the last dose of study drug administration.
- •Lumbar puncture, bone marrow aspiration/biopsy, or placement of central venous
- •access device are not considered major procedures.
- •- A diagnosis of post-transplant lymphoproliferative disease (PTLD)
- •-Patients who are within 6 months of an allogeneic bone marrow transplant
研究者
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