A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 117
- 主要终点
- Relapse-free Survival (RFS)
研究概览
简要总结
The purpose of this study is to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
详细描述
Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergoing allogeneic hematopoietic stem cell transplant (HCT) will be randomized to receive gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants will be stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Gilteritinib
Participants received gilteritinib 120 milligrams (mg) (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-defined discontinuation criterion was met.
干预措施: gilteritinib (Drug)
Placebo
Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-defined discontinuation criterion was met.
干预措施: Placebo (Drug)
结局指标
主要结局
Relapse-free Survival (RFS)
时间窗: From the date of randomization up to 64 months and 22 days
RFS was defined as the time from the date of randomization until the date of documented morphological relapse, or death from any cause, whichever occurred first. Morphological relapse was defined as documentation of any of the following events: * BM blasts ≥ 5% (not attributable to regenerating BM) * Any circulating blasts (not attributable to regenerating BM or growth factors) * Presence of extramedullary blast foci per Revised International Working Group (RIWG) criteria * The earliest date of any of the relapse event was used for RFS.
次要结局
- Overall Survival (OS)(From the date of randomization up to 64 months and 22 day)
- Number of Participants With Treatment Emergent Adverse Events (TEAE)(From the date of randomization through 30 days after the last dose, up to 25 months and 22 days)
- Karnofsky Performance Status Scores(Baseline, month 24)
- Percentage of Participants With Non-relapse Mortality (NRM)(From the date of randomization up to 64 months and 22 days)
- Event-free Survival (EFS)(From the date of randomization up to 64 months and 22 days)
- Percentage of Participants With Treatment Emergent Acute Graft vs. Host Disease (aGVHD)(From the date of randomization up to 6 months)
- Percentage of Participants With Treatment Emergent Chronic GVHD at 12 Months(From the date of randomization up to 12 months)
- Percentage of Participants With Treatment Emergent Chronic GVHD at 24 Months(From the date of randomization up to 24 months)
- Percentage of Participants With FMS-like Tyrosine Kinase 3/Internal Tandem Duplication (FLT3/ITD) Minimal Residual Disease (MRD)(From the date of randomization up to 64 months and 22 days)
- Percentage of Participants With Relapse(From the date of randomization up to 64 months and 22 days)
- Percentage of Participants With Treatment Emergent Infection by Severity.(From the date of randomization through 30 days after the last dose, up to 25 months and 22 days)