Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia in Remission Using HLA-matched Sibling Donors, HLA-matched Unrelated Donors, or HLA-mismatched Familial Donors-A Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Cumulative incidence of relapse
研究概览
简要总结
[Study Objectives]
- To evaluate the efficacy of allogeneic hematopoietic cell transplantation (HCT) in patients with acute lymphoblastic leukemia (ALL) in the first or second complete remission (CR). The efficacy of the treatment will be measured in terms of the frequency of relapse and duration of remission (the primary endpoints).
- The secondary end points of the study include; engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, transplantation-related mortality, leukemia free survival, and overall survival.
详细描述
1.0 STUDY OBJECTIVES
1.1. To evaluate the efficacy of allogeneic hematopoietic cell transplantation (HCT) in patients with acute lymphoblastic leukemia (ALL) either who have achieved complete remission (CR) after induction chemotherapy or who experienced recurrent leukemia then achieved second CR after salvage chemotherapy. The efficacy of the treatment will be measured in terms of the frequency of relapse after HCT and the duration of remission (the primary endpoints).
1.2. The secondary end points of the study include; engraftment (absolute neutrophil count over 500/㎕, unsupported platelet count over 20,000/㎕), donor chimerism at 2 and 4 weeks after HCT, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), lymphocyte subset recovery at 1, 2, 3, 6, and 12 months, cytomegalovirus (CMV) reactivation/CMV disease, Epstein-Barr virus (EBV) reactivation/post-transplant lymphoproliferative disorder, transplantation-related mortality (100 day, 1 year), leukemia free survival, and overall survival.
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- The hematopoietic cell donors in the study will include; HLA-matched sibling donors, HLA-matched unrelated donors, and HLA-mismatched family members, so that the majority of patients who achieve CR after induction or salvage chemotherapy will undergo allogeneic HCT as a part of consolidation therapy.
2.0 BACKGROUND INFORMATION
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ALL who achieve CR after induction chemotherapy.
- •Patients with recurrent ALL that went into second CR after salvage chemotherapy, except those who had undergone allogeneic HCT previously.
- •Patients should be 15 years of age or more, and 75 years of age or less.
- •The performance status of the patients should be 70 or over by Karnofsky performance scale.
- •Patients should have adequate hepatic function (bilirubin less than 2.0 mg/dl, AST less than three times the upper normal limit).
- •Patients must have adequate renal function (creatinine less than 2.0 mg/dl).
- •Patients must have adequate cardiac function (ejection fraction > 40% on MUGA scan).
- •Patients must sign informed consent.
排除标准
- •Presence of significant active infection
- •Presence of uncontrolled bleeding
- •Any coexisting major illness or organ failure
- •Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- •Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- •Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
研究组 & 干预措施
alloHCT
alloHCT arm: For HLA-matched sibling HCT, if a patient is 55 years old or less and without co-morbidity, the patient will receive Bu-Cy conditioning therapy and be transplanted with bone marrow cells. Patients who are older than 55 years or with co-morbidity will receive Bu-Flu-ATG conditioning and be transplanted with mobilized peripheral blood hematopoietic cells. For HLA-matched unrelated donor or HLA-mismatched familial donor HCT, the patient will receive Bu-Flu-ATG conditioning and well be transplanted with mobilized peripheral blood hematopoietic cells.
干预措施: alloHCT (Procedure)
结局指标
主要结局
Cumulative incidence of relapse
时间窗: 3 years
次要结局
- leukemia free survival(3 years)
- engraftment rate(100 days)
- secondary graft failure rate(100days, 1year)
- degree of immune recovery(6 months, 1year)
- duration of remission(3 years)
- donor chimerism(1year, 2year, 3year)
- transplantation-related mortality rate(3 years)
- overall survival rate & median survival time(3 years)
- Incidence & severity of acute GVHD(100 days)
- incidence and severity of chronic GVHD(1year, 2year, 3year)
- cumulative incidence and severity of infection(3years)
研究者
Dae-Young Kim
Assistant Professor
Asan Medical Center