NCT02743351已完成1 期
A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of ProTmune™ (ex Vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects With Hematologic Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 23
- 主要终点
- Percentage of Participants With Cumulative Incidence of Grade II to IV aGvHD Through Day +100 Based on Investigator Assessment
研究概览
简要总结
This study is a Phase 1, non-randomized, open-label/Phase 2 randomized, blinded study of ProTmune (ex vivo programmed mobilized peripheral blood cells) versus non-programmed mobilized peripheral blood cells for allogeneic hematopoietic cell transplantation (HCT) in adult subjects aged 18 years and older with hematologic malignancies. A total of 88 study subjects were treated in the trial at approximately 15 centers in the US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Male and female patients aged 18 years and older, inclusive;
- •Patients must have a hematologic malignancy for which allogeneic hematopoietic peripheral blood cell transplantation is deemed clinically appropriate.
- •Eligible diseases and stages include the following:
- •Acute myeloid leukemia
- •Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement
- •Myelodysplastic Syndrome
- •Chronic myelogenous leukemia
- •Availability of a suitable 8/8 HLA-A, -B, -C, and -DRB1-matched unrelated mPB donor;
- •mBP donor collection that meets protocol specifications;
- •Adequate performance status, defined as Karnofsky score greater than or equal to 70%;
- •For female patients of childbearing potential, all of the following criteria must be met:
- •They are not pregnant (i.e., female patients must have a negative serum pregnancy test at screening);
- •They are not breastfeeding;
- •They do not plan to become pregnant during the study; and
- •They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile.
- •For male patients, agreement to use condoms with spermicide during sexual intercourse from screening to the end of study; and
- •Willingness and ability to sign an IRB/IEC-approved ICF before performance of any study-specific procedures or tests and to comply with protocol visits, and study procedures.
排除标准
- •Phase 1 only: Known bone marrow fibrosis; Phase 2 only: Bone marrow fibrosis grade 3 (severe) or greater;
- •Positive serology for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) at any time prior to enrollment;
- •Currently uncontrolled bacterial, viral, or fungal infection (progression of clinical symptoms despite therapy);
- •Prior autologous or allogeneic HCT;
- •Active malignancy, other than the one for which the allogeneic mPB transplant is being performed, within 12 months of enrollment, excluding superficial basal cell and carcinoma in situ cervical cancer;
- •Pulmonary disease, renal dysfunction, hepatic disease, cardiac disease, neurologic disease;
- •Participation in another clinical trial involving an investigational product within 30 days prior to screening; or
- •Any condition or therapy, which, in the opinion of the Investigator, might pose a risk to the patient or make participation in the study not in the best interest of the patient.
结局指标
主要结局
Percentage of Participants With Cumulative Incidence of Grade II to IV aGvHD Through Day +100 Based on Investigator Assessment
时间窗: 100 days post-HCT
Acute GvHD (aGvHD) is assessed by assigning the clinical stage for the target organs (skin, liver, and gut) along with assigning an overall grade based on the minimum degree of organ involvement required to confer that grade. Grade II is defined as Stage 1 skin, Stage 1 liver, or Stage 1 GI; Grade III is defined as any Stage 1-3 skin, and Stage 2-3 liver, or Stage 2-4 GI; Grade IV is defined as Stage 4 skin, or Stage 4 liver and any Stage GI. A higher overall grade indicates a more severe outcome. The cumulative incidence of CIBMTR Grade II to IV aGVHD through approximately 100 days following HCT is measured by the percentage of participants who experienced grade II to IV aGVHD. The cumulative incidence and the associated 95% confidence interval are estimated using a competing risk analysis with death and relapse without grade II-IV aGvHD as a competing risk.
次要结局
- 1-year GvHD-free, Relapse-free Survival (GRFS)(365 days post-HCT)
- Percentage of Subjects Alive Without Relapse and Without Moderate or Severe cGvHD at Day +365 - mITT Population(365 days post-HCT)
研究者
研究点 (23)
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