NCT02796261Unknown3 期
A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 343
- 试验地点
- 78
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
详细描述
This study will consist of 4 study periods of up to 50 months in total, consisting of:
Screening Period - A maximum screening duration of 4 weeks.
Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.
Follow-Up Period - Up to approximately 36 months, or until patient death.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
- •First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:
- •Gd-contrast lesion margins are not clearly defined,
- •Gd-contrast lesions are only measurable in one dimension,
- •Gd-contrast lesion has two perpendicular diameters less than 10 mm,
- •Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
- •Recent histopathological confirmation of WHO grade 3 AA
- •Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
- •Completion of EBRT ≥ 6 months prior to randomization.
- •A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.
- •Karnofsky Performance Status (KPS) score of ≥ 70.
排除标准
- •Patients who meet any of the following exclusion criteria are not eligible for study participation:
- •MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
- •Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
- •Prior systemic therapy for recurrence of AA.
- •Presence of extracranial or leptomeningeal disease.
- •Prior lomustine use.
- •Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
- •Pregnant or breastfeeding.
研究组 & 干预措施
Eflornithine + Lomustine
Experimental
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
干预措施: Eflornithine (Drug)
Eflornithine + Lomustine
Experimental
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
干预措施: Lomustine (Drug)
Lomustine
Active Comparator
Lomustine dosed every 6 weeks
干预措施: Lomustine (Drug)
结局指标
主要结局
Overall survival
时间窗: 4 years
次要结局
- Objective response rate (ORR)(4 years)
- Progression-free survival (PFS)(4 years)
研究者
研究点 (78)
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相关资讯
Eflornithine Plus Lomustine Improves Survival in IDH-Mutant Grade 3 Astrocytoma- The STELLAR trial showed that eflornithine combined with lomustine significantly improved overall survival in recurrent grade 3 IDH-mutant astrocytoma patients.
- Median overall survival increased to 34.9 months with the combination therapy, compared to 23.5 months with lomustine alone.
- Progression-free survival also saw a significant boost, with a median of 15.8 months in the combination arm versus 7.2 months in the lomustine arm.
- The combination therapy was generally well-tolerated, with a safety profile consistent with previous studies, offering a potential new treatment option.last yearEflornithine Plus Lomustine Improves Survival in IDH-Mutant Anaplastic Astrocytoma- The phase 3 STELLAR trial demonstrated that eflornithine combined with lomustine significantly improved survival in patients with recurrent _IDH_-mutant anaplastic astrocytoma.
- Patients treated with eflornithine plus lomustine showed a statistically significant and clinically meaningful extension in overall survival compared to lomustine alone.
- The study's findings highlight a potential new treatment option for this aggressive brain tumor subtype, addressing a critical unmet need in neuro-oncology.
- These results may change the standard of care for patients with recurrent _IDH_-mutant anaplastic astrocytoma, offering a more effective therapeutic strategy.last yearEflornithine and Lomustine Combination Shows Survival Benefit in Recurrent Astrocytoma- The combination of eflornithine and lomustine significantly improved overall survival (OS) in patients with recurrent grade 3 IDH mutant astrocytoma in a Phase 3 trial.
- Median OS increased to 34.9 months with the combination therapy, compared to 23.5 months with lomustine alone (HR = 0.64, p = 0.016).
- Progression-free survival (PFS) also saw a correlating benefit, with median PFS of 15.8 months versus 7.2 months (HR = 0.58, p = 0.015).
- The combination therapy was generally well-tolerated, with a safety profile consistent with previous studies, offering a potential new treatment option.last year