Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 43
- 主要终点
- Retrospective WECARE Survey
研究概览
简要总结
To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and/or inotuzumab ozogamicin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
- •Who either:
- •Experienced refractory or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.
- •Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriah™ (CTL019, tisagenlecleucel), blinatumomab or
- •Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age.
- •Inclusion Criteria (Arm B)
- •Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
- •Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age
- •Patients who are either:
- •Undergoing evaluation for leukapheresis for planned standard of care tisagenlecleucel therapy, or planned for therapy with blinatumomab or inotuzumab. (Patients who received prior tisagenlecleucel, blinatumomab or inotuzumab on an established clinical trial and are now scheduled for commercial CAR, blinatumomab or inotuzumab therapy are also eligible) Or
- •Experienced refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
- •Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects <18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those > 7 years of age, when appropriate, according to institutional procedures.
排除标准
- 未提供
研究组 & 干预措施
Arm A (Retrospective data)
Participants who have undergone standard of care tisagenlecleucel therapy, Participants will received a questionnaire study using patient reported outcomes.
干预措施: Questionnaire for patients receiving therapy (Other)
Arm B (Prospective data)
Patients enrolled in ARM B will be asked to participate in the biological sample collection. Participants will received a questionnaire
干预措施: Questionnaire for patients receiving therapy (Other)
结局指标
主要结局
Retrospective WECARE Survey
时间窗: up to 12 months post infusion
Surveys will be administered at a single time point post-CAR
WECARE-Survey
时间窗: at baseline
Participant will take part in a one-time questionnaire to address CAR specific questions. WECARE survey, consists of questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language)
次要结局
- duration of remission (DOR)(at baseline up to 12 months post infusion)
- overall survival (OS)(at baseline up to 12 months post infusion)
- event-free-survival (EFS)(at baseline up to 12 months post infusion)