Phase I Study of Ex Vivo Expanded Donor Cord Blood T-Lymphocyte Infusion in Post-Transplant Relapsed Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD) of ex vivo expanded T-cells defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30%
研究概览
简要总结
This phase I trial studies the side effects and best dose of donor cord blood T-cells after stem cell transplant in treating patients with relapsed hematological malignancies. After umbilical cord blood transplant, stem cells are collected from the donor's cord blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by treatment. Removing the T cells and treating them in the laboratory before infusing them in the patient may also help boost the patient's immune system.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the safety and maximum tolerated dose (MTD) of infusion of ex vivo expanded cord blood T cells (CLI), in cord blood (CB) transplant recipients with relapsed hematological malignancies.
SECONDARY OBJECTIVES:
I. To determine the complete remission rate and overall response as a result of CLI infusion.
II. To determine the effect of CLI infusion on the chimerism. III. To evaluate the incidence rate and grade of acute graft-versus-host disease (GvHD) after CLI infusion.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Umbilical cord blood (UCB) recipients with underlying hematological malignancies presenting with post-transplant relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
- •UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
- •Performance score of at least 80% by Karnofsky or performance status (PS) < 3 (Eastern Cooperative Oncology Group [ECOG]) (age >= 12 years), or Lansky Play-performance scale of at least 60% or greater (age < 12 years)
- •Negative beta human chorionic gonadotropin (HCG) or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study
- •Patient or patient's legal representative, parent(s) or guardian able to sign informed consent
排除标准
- •Human immunodeficiency virus (HIV) positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)
- •Patients with active (untreated) central nervous system (CNS) disease
- •Any active GVHD
- •Active invasive infections
- •Pregnant or breast-feeding
研究组 & 干预措施
Treatment (T-cell infusion)
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
干预措施: Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion (Procedure)
Treatment (T-cell infusion)
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
干预措施: Umbilical Cord Blood-Derived Lymphocyte Therapy (Biological)
Treatment (T-cell infusion)
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
干预措施: Aldesleukin (Biological)
结局指标
主要结局
Maximum tolerated dose (MTD) of ex vivo expanded T-cells defined as the highest dose for which the probability of toxicity is closest to 30% without exceeding 30%
时间窗: Up to day 45
Dose limiting toxicity is defined as grade IV graft-versus-host disease (GVHD), grades 3-4 acute GVHD occurring within 45 days of the study T cell infusion, grade 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic), grade 4 cytopenia, or any grade 4 or 5 organ based (non-hematologic) toxicity.
次要结局
- Incidence of adverse events by grade by ex vivo expanded cord blood T cells dose and overall(Up to day 100)
- Numbers of patients treated at the MTD with grade 2-4 GVHD(Up to day 100)
- Proportion of patients with remission post-infusion(Up to day 100)
- Proportion of patients achieving chimerism post-infusion(Up to day 100)
- Proportion of patients with cytopenia post-infusion(Up to day 100)
- Proportion of patients that relapse after infusion(Up to day 100)
- Disease-free survival(Up to day 100)