A Retrospective Analysis of Inotuzumab Ozogamicin (InO) Usage in Adult Patients With Relapsed/Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO
研究概览
简要总结
The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment.
This retrospective Study enroll adult patients who:
- were CD22 positive (a molecule in the body that stops the over activity of the immune system)
- Received only InO for the treatment of B-cell ALL that occurred again after the last treatment
- were Philadelphia chromosome positive (which occurs because of changes in genes)
- failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division).
The patient data except their personal details are collected from a hospital based electronic medical record in India.
In this study the effectiveness and safety of InO will be studied after it was released to the market.
To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India:
- in whom the disease occurred again
- or those who never showed any improvement to earlier treatments
- now being treated with InO alone
Around 55 patients who have taken InO are likely to be enrolled in the study.
Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 aged ≥18 years old at the initiation of InO treatment
- •Patients with relapsed/refractory B-cell ALL
- •Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive
- •Ph+ patients who have failed treatment with at least 1 TKI
排除标准
- •Patient not completing at least 1 cycle of InO therapy • Patient on InO in combination with chemotherapy
研究组 & 干预措施
Adult relapsed or refractory B Cell ALL
Adult patients whose B Cell ALL has occurred again after the last treatment or patients who never responded to prior treatment
干预措施: Inotuzumab Ozogamicin (Drug)
结局指标
主要结局
Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO
时间窗: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count.
Number of Participants Who Achieved Complete Remission (CR) or Complete Remission With Incomplete Hematological Recovery (CRi) Following Treatment With InO, Classified Per Number of Lines of Salvage Therapies Prior to InO Initiation
时间窗: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5 percent (%) bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \[more than\] \>100\*10\^9 cells/liter \[L\] and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Salvage therapy is use of drugs after standard conventional chemotherapeutic regimens have failed to achieve remission.
Number of Participants Who Achieved CR or CRi Following Treatment With InO, Classified Per High Burden and Low Burden Disease
时间窗: From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study)
CR was defined as 5% bone marrow blasts, no evidence of disease in the bone marrow, and recovery of peripheral blood count (platelet count of \>100\*10\^9 cells/L and absolute neutrophil count of \>1\*10\^9 cells/L). CRi was defined as 5% bone marrow blasts and no evidence of disease in the bone marrow, but with incomplete recovery of peripheral blood count. Disease burden was defined using percentage of bone marrow blasts (BMB). In this outcome measure low disease burden indicated BMB \<50% and high disease burden indicated BMB \>=50%.
次要结局
- Number of Participants Who Achieved Minimal Residual Disease (MRD) Negativity Following Initiation of Ino Among Those Who Had CR/CRi(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants Who Achieved MRD Negativity Classified Per Number of Lines of Salvage Therapies Following Initiation of InO Among Those Who Had CR/CRi(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants Who Achieved MRD Negativity Classified Per High Burden and Low Burden Disease Following Initiation of InO Among Those Who Had CR/CRi(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants Achieving MRD Negativity Following Initiation of InO Among Those Who Had CR/CRi in Elderly Participants (>65 Years)(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Median Number of Cycles of InO Treatment(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Median Number of Cycles of InO Needed to Attain CR/CRi(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Mean Number of Cycles of InO Needed to Attain CR or CRi Classified Per Number of Lines of Salvage Therapies(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Duration of Remission (DOR)(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants Categorized as Per InO Doses(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants With InO Dose Modifications(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants Who Received Concomitant Medications(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants Who Proceeded to Hematopoietic Stem Cell Transplantation (HSCT)(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Who Achieved CR/CRi and MRD Negativity(6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per Number of Lines of Salvage Therapies(6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Participants Classified Per High Burden and Low Burden Disease(6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Survival Rate at 6 and 12 Months in Transplanted and Non-Transplanted Elderly Participants (>65 Years)(6 and 12 months post initiation of InO treatment; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants Categorized According to Cause of Death(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Relapse Free Survival (RFS) in All Participants and Participants With or Without Follow-up HSCT(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Percentage of HSCT Transplanted Participants With VOD and Percentage of HSCT Non-transplanted Participants With VOD(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Percentage of Participants With VOD in Participants Classified Per Number of Lines of Salvage Therapies(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Percentage of Participants With VOD Classified Per High Burden and Low Burden Disease(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Percentage of Participants With VOD in Elderly Participants (>65 Years)(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants With Grade 3/4 Treatment Related Liver Toxicity (Hepatobiliary Disorder) Adverse Events (TEAEs) Following InO Initiation(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants With Hematological Toxicities Following InO Initiation(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))
- Number of Participants With Extramedullary Disease (EMD) or Lymphoblastic Lymphoma (LBL) Who Achieved CR or CRi(From InO treatment initiation (Apr 2018) till end of follow-up (Apr 2023) [Maximum up to 61 Months]; data retrospectively collected from 08-Mar-2023 to 10-Jul-2023 (approximately 4 months of this study))