A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY OF INOTUZUMAB OZOGAMICIN IN CHINESE ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 44
- 试验地点
- 15
- 主要终点
- Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria
研究概览
简要总结
This is an open-label, single-arm, multicenter study in Chinese patients with relapsed or refractory CD22-positive B-cell ALL. The objective of the study is to confirm the efficacy, safety, and PK of inotuzumab ozogamicin in patients with relapsed or refractory B-cell ALL from mainland China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female participants, age 18 years or older at screening.
- •Relapsed or refractory CD22-positive ALL.
- •Subjects with Philadelphia chromosome-positive (Ph+) ALL must have failed standard treatment with at least one tyrosine kinase inhibitor.
- •Patients in Salvage 1 with late relapse should be deemed poor candidates for reinduction with initial therapy.
- •Patients with lymphoblastic lymphoma and bone marrow involvement ≥5% lymphoblasts by morphologic assessment.
- •ECOG performance status 0-
- •Adequate renal and hepatic function, and negative pregnancy test for women of childbearing potential.
排除标准
- •Subjects with isolated extramedullary relapse or active central nervous system (CNS) leukemia.
- •Prior allogeneic hematopoietic stem cell transplant (HSCT) or other anti-CD22 immunotherapy within 4 months, or active graft versus host disease (GvHD) at study entry.
- •Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS).
研究组 & 干预措施
inotuzumab ozogamicin
Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
干预措施: inotuzumab ozogamicin (Drug)
结局指标
主要结局
Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) as Per Investigator's Assessment According to a Modified Cheson Criteria
时间窗: From InO treatment initiation on Day 1 to CR or CRi (maximum up to 30.1 weeks of treatment exposure)
CR: disappearance of leukemia as indicated by \<5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) \>=1000 per microliter (/mcL) and platelets \>=100,000/mcL. C1 extramedullary disease (EMD) status was required (disappearance of all measurable and non-measurable EMD with the exception of lesions for which following must be true: participants with at least 1 measurable lesion, all nodal masses \>1.5 centimeter (cm) in greatest transverse diameter (GTD) at baseline regressed to \<=1.5 cm in GTD and nodal masses \>=1 cm and \<=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 (SPD). No new lesions. Spleen and other previously enlarged organs must have regressed in size and must not be palpable. All diseases were assessed using the same technique as at baseline. CRi: CR except with ANC \<1000/mcL and/or platelets \<100,000/mcL.
次要结局
- Duration of Remission (DoR)(From date of first response in responders (CR/CRi) to the date of disease progression (objective progression, relapse from CR/CRi), death due to any cause, whichever occurred first (including post-study treatment follow-up disease assessment))
- Percentage of Participants With Minimal Residual Disease (MRD) Negativity Among Who Achieved CR/CRi(From CR/CRi till MRD negativity achieved (maximum up to 30.1 weeks of treatment exposure))
- Progression-free Survival (PFS)(From date of first dose to the date of disease progression (objective progression, relapse from CR/CRi), or death due to any cause, whichever occurred first)
- Overall Survival (OS)(From date of first dose to the date of death due to any cause or censoring, whichever occurred first)
- Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT)(From InO treatment initiation till study completion)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5(From InO treatment initiation till study completion)
- Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) Based on NCI CTCAE Version 5(From InO treatment initiation till study completion)
- Number of Participants With TEAEs - Treatment Related Based on NCI CTCAE Version 5(From InO treatment initiation till study completion)
- Number of Participants With AEs According to Severity Based on NCI CTCAE Version 5(From InO treatment initiation till study completion)
- Number of Participants With Hematology Laboratory Parameters of Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline(From InO treatment initiation till study completion)
- Number of Participants With Hematology Chemistry Parameters of Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline(From InO treatment initiation till study completion)
- Number of Participants With Veno-occlusive Disease (VOD)(From InO treatment initiation till study completion)
- Maximum Plasma Concentration (Cmax) of InO on Day 1 of Cycle 1 and Cycle 4(Cycle 1: Pre-dose (0 hour), 1, 2 and 4 hours post-dose on Day 1; Cycle 4: Pre-dose (0 hour), and 1 hour post-dose on Day 1)
- Pre-dose Concentration (Ctrough) of InO on Day 1 of Cycle 4(Pre-dose (0 hour) on Day 1 of Cycle 4)
- Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) to InO(From InO treatment initiation till study completion)