A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate-2 or High Risk Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 19
- 试验地点
- 34
- 主要终点
- Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
研究概览
简要总结
This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).
详细描述
In the phase 1 portion of the study, escalating doses of 33A will be evaluated in combination with azacitidine, and a dose of 33A will be selected to proceed to phase 2. The phase 2 portion of the study is randomized, double-blind and placebo-controlled; it is designed to compare the overall response rate (ORR) between 2 study arms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
- •Previously untreated for Myelodysplastic Syndrome (MDS)
- •Age ≥18 years of age.
- •Eligible for therapy with azacitidine.
- •Life expectancy of at least 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Adequate baseline laboratory parameters.
排除标准
- •Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
- •History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
- •Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).
- •Candidates for allogeneic stem cell transplant at the time of screening.
研究组 & 干预措施
33A + azacitidine
Vadastuximab talirine plus azacitidine
干预措施: vadastuximab talirine (Drug)
33A + azacitidine
Vadastuximab talirine plus azacitidine
干预措施: Azacitidine (Drug)
Placebo + azacitidine
placebo plus azacitidine
干预措施: Azacitidine (Drug)
Placebo + azacitidine
placebo plus azacitidine
干预措施: Placebo (for 33A) (Drug)
结局指标
主要结局
Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study
时间窗: Up to 1 year
A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.
Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study
时间窗: N/A - End point not assessed
次要结局
- Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities(Up to 1 year)
- Complete Response Rate (CR)(N/A - End point not assessed)
- Duration of Response (DOR) Rate(N/A - End point not assessed)
- Overall Survival (OS)(N/A - End point not assessed)
- Hematologic Improvement (HI) Rate(N/A - End point not assessed)
- Progression Free Survival (PFS)(N/A - End point not assessed)
- Rate of Transformation to Acute Myeloid Leukemia (AML)(N/A - End point not assessed)