A Prospective Study of Duffy-null Associated Absolute Neutropenia and Its Impact on Chemotherapy Dosing
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 886
- 试验地点
- 1
- 主要终点
- The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI <85%
研究概览
简要总结
The goal of this clinical trial is to:
- In Phase 1 (observational) to develop an algorithm for treatment of Duffy-null positive patients for chemotherapy dosing
- In Phase 2 (interventional), use the algorithm created in phase 1 to adjust chemotherapy dosing for Duffy-null patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must self-identify as being of Middle Eastern or African descent.
- •Participant must be diagnosed with histologically or cytologically confirmed solid organ cancer and be treatment naive.
- •Melanoma is allowed; sarcoma is not eligible.
- •Secondary malignancies are allowed.
- •Participants who have received only surgery alone as treatment are eligible
- •Participant must be between the ages of 18-
- •Participant or their legally authorized representative (LAR) must be able to understand a written informed consent document and be willing to sign it.
排除标准
- •Participants with active and uncontrolled bacterial, viral, or fungal infection requiring IV antibiotics.
- •Participants may be eligible for the study if the infection is deemed to be under control per investigator's discretion.
- •Participants who have ever received cytotoxic chemotherapy.
- •Those who have already started a chemotherapy regimen with moderate likelihood of developing neutropenia will be considered for enrollment at the principal investigator's discretion.
- •Participants who are receiving concurrent chemo-radiation treatment.
- •Participants who are taking any other investigational drugs.
- •Participants who are pregnant or breastfeeding.
- •Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan.
研究组 & 干预措施
Duffy-null phenotype positive
In phase 2, Patients with a positive Duffy-null blood test plus standard of care chemotherapy with dose adjustment according to an algorithm created in phase 1 of this study.
干预措施: Standard of Care chemotherapy Following an Algorithm (Drug)
Non-Duffy-null
In phase 2, patients with a negative Duffy-null blood test plus standard of care chemotherapy. Delays/modifications based on standard CTCAE (Common Terminology Criteria for Adverse Events) grading.
干预措施: Standard of Care chemotherapy following CTCAE criteria (Drug)
结局指标
主要结局
The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI <85%
时间窗: 5 months after the start of chemotherapy
The proportion of patients with chemotherapy RDI (relative dose intensity) \<85% will be estimated separately for the Duffy-null and non-Duffy-null groups. The primary measure of interest is the absolute between-group difference in proportions. A one-sided 90% confidence interval (equivalently, a two-sided 80% confidence interval) will be constructed for this difference. Results will be interpreted relative to the prespecified clinically meaningful threshold of 15% to inform the go/no-go decision for Phase 2. Formal hypothesis testing will be conducted using a one-sided significance level of 10% based on Fisher's exact test.
The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI (relative dose intensity) <85% after implementation of a new purposed algorithm from Phase 1.
时间窗: 5 months after the start of chemotherapy
The absolute difference in the proportion of patients with chemotherapy RDI \<85% between the Duffy-null group treated under the purposed dosing algorithm and the non-Duffy-null group treated under standard of care will be estimated. A non-inferiority analysis will be performed using a prespecified margin of 7.5%. A two-sided 80% confidence interval (equivalently, a one-sided 90% confidence interval) will be constructed, and non-inferiority will be concluded if the upper bound of the confidence interval is less than 7.5%.
次要结局
- Incidence rates of fever, infection, hospitalization, and treatment-related mortality in the first five months of chemotherapy treatment(5 months after the start of chemotherapy)
研究者
Vijendra Singh
Principal Investigator
Barbara Ann Karmanos Cancer Institute