Real World Asparaginase Therapy Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy
研究概览
简要总结
This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy) therapy.
详细描述
Primary Objective
- To estimate the rate of high-grade toxicities which occur during therapy for acute lymphoblastic leukemia/ lymphoma in patients receiving asparaginase-containing standard of care therapy.
This study will involve the collection of data about the participants ALL/LLy, treatment, side effects of treatment and leukemia/ lymphoma's response to treatment. Data collected on other research studies participants are enrolled on will also be used for this research study.
Blood samples will be collected and liver fibroscans (liver ultrasounds) will be done at different time points while the participant is receiving treatment for ALL/LLy. The time points will depend on what treatment they receive and will correspond to days on their treatment roadmap.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia
- •Enrolled on INITIALL and no more than 10 days after initiation of post-INITIALL therapy
- •Post-INITIALL therapy is:
- •Standard of Care (SOC)/Non Protocol Treatment Plan (NPTP) as per Total therapy or
- •SJALL23T and not scheduled to receive venetoclax
排除标准
- •Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
研究组 & 干预措施
Non-protocol therapy /standard of care therapy
Participants receiving non -protocol standard if care (SOC) treatment.
SJALL23T (NCT06390319) protocol therapy
Participants receiving protocol therapy on SJALL23T and not receiving investigational drug.
结局指标
主要结局
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy
时间窗: Approximately 2½ to 3 years
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy
时间窗: Approximately 2½ to 3 years
The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy
时间窗: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy
时间窗: Approximately 2½ to 3 years
Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.
Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment
时间窗: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment
时间窗: Approximately 2½ to 3 years
Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.
次要结局
未报告次要终点