AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 326
- 试验地点
- 192
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
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
- •CD22 expression
- •Adequate liver and renal functions
排除标准
- •Isolated extramedullary disease
- •Active Central Nervous System [CNS] disease
研究组 & 干预措施
Arm B
干预措施: FLAG (fludarabine, cytarabine and G-CSF) (Drug)
Arm A
干预措施: inotuzumab ozogamicin (Drug)
Arm B
干预措施: HIDAC (high dose cytarabine) (Drug)
Arm B
干预措施: cytarabine and mitoxantrone (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.
Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
时间窗: Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose
CR was the disappearance of leukemia indicated by less than (\<) 5 percent (%) marrow blasts \& absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) \& platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable \& non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (\>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm \& ≤1.5 cm in GTD at baseline must have regressed to \<1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen \& other previously enlarged organs must have regressed in size \& must not be palpable) was required. CRi was defined as CR except ANC \<1000/μL \&/or platelets \<100,000/μL.
次要结局
- Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)(Up to approximately 4 weeks (EoT) from last dose of study drug)
- Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)(Up to 2 years from randomization)
- Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)(Up to 19 weeks from last dose)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score(Day 1 of each cycle prior to dosing and EoT)
- Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing(Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4)
- Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score(Day 1 of each cycle prior to dosing and EoT)
- Progression-Free Survival (PFS)(Up to 2 years from randomization)
- Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)(Up to approximately 4 weeks (EoT) from last dose of study drug)
- Change From Baseline in EQ-5D VAS(Day 1 of each cycle prior to dosing and EoT)
- Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT(Up to 2 years from randomization)