NCT04762875终止2 期
A Phase II Study Evaluating the Safety and Efficacy of MGTA-145 in Combination With Plerixafor for the Mobilization and Transplantation of HLA-Matched Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies
Ensoma8 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2021年6月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 8
- 主要终点
- HSC Yield in Apheresis Product
研究概览
简要总结
This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies. MGTA-145, the new medicine, will be given with plerixafor.
详细描述
This is a Phase II, open-label, multicenter, prospective study of MGTA-145 + plerixafor mobilized HLA-matched sibling and matched unrelated donor allografts for myeloablative hematopoietic stem cell transplantation (HSCT) in recipients with hematological malignancies. Donors will undergo 1 or 2 days of mobilization and apheresis.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donor Inclusion Criteria:
- •Donor medical suitability and eligibility will be determined following Institution or NMDP/Be The Match standards
- •Age 18-65 years old at the time of signing informed consent
- •8/8 (HLA- A, B, C, and DRB1) HLA-matched sibling or volunteer unrelated donor
- •Fulfill Institution or NMDP/Be The Match criteria to serve as a mobilized blood cell donor
- •Serum creatinine < 1.5 x institution upper limit of normal (ULN) or estimated creatinine clearance (CRCL) > 50 mL/min using the Modification of Diet in Renal Disease Study (MDRD) equation or similar method
- •Recipient Inclusion Criteria:
- •At least 18 years old at the time of signing informed consent
- •Has an available 8/8 (HLA- A, B, C, and DRB1) HLA-matched sibling or volunteer unrelated donor willing to donate peripheral blood stem cells (PBSC) for transplant
- •Fulfill additional individual Transplant Center Criteria for transplant beyond NMDP/Be The Match criteria
- •One of the following diagnoses:
- •Acute myelogenous leukemia (AML) in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts. Documentation of bone marrow assessment will be accepted within 45 days prior to the date of consent.
- •Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with ≤ 5% marrow blasts and no circulating blasts. Documentation of bone marrow assessment will be accepted within 45 days prior to the date of consent.
- •Patients with myelodysplasia (MDS) with no circulating blasts and with less than 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with < 5% or 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the date of consent.
- •Cardiac function: Left ventricular ejection fraction at least 45% based on most recent echocardiogram or MUGA results obtained via standard of care
- •Estimated creatinine clearance acceptable per local institutional guidelines
- •Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin at least 50% and forced expiratory volume in first second (FEV1) predicted at least 50% based on most recent DLCO results obtained via standard of care
- •Liver function acceptable per local institutional guidelines
- •Karnofsky performance status (KPS) of 70% or greater
- •Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score of 4 or less
排除标准
- •Donor Exclusion Criteria:
- •Donor unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- •Donor already enrolled on another investigational agent study
- •Pregnant or breastfeeding females, sexually active female and male donors not willing or able to use adequate contraception, or males who do not agree to refrain from donating sperm, from the time of consent through 3 months after treatment with MGTA-145 + plerixafor
- •Recipient Exclusion Criteria:
- •Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
- •Subject whose donor does not meet the eligibility criteria and is a screen fail
- •Subjects with a prior allogeneic transplant
- •Subjects with active, uncontrolled infection at the time of the transplant preparative regimen
- •Pregnant or breastfeeding females, sexually active female or male subjects not willing or able to use adequate contraception, or males who do not agree to refrain from donating sperm, from the time of consent through 3 months after PBSC infusion
- •Subjects with clinical evidence of active Central Nervous System (CNS) tumor involvement as evidenced by documented disease on examination of spinal fluid or MRI within 45 days of start of conditioning
- •A condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of primary and secondary endpoints
- •Planned treatment with a new investigational agent from the time of transplant through 30 days post-transplant
研究组 & 干预措施
Single dose MGTA-145 plus plerixafor followed by apheresis
Experimental
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
干预措施: MGTA-145 (Biological)
Single dose MGTA-145 plus plerixafor followed by apheresis
Experimental
MGTA-145 in combination with plerixafor followed by apheresis on one or two consecutive days
干预措施: Plerixafor (Biological)
结局指标
主要结局
HSC Yield in Apheresis Product
时间窗: Up to 2 days
Number of subjects with adequate number of hematopoietic stem cells (≥ 2.0 x 10\^6 CD34+ cells/kg) in one apheresis setting.
次要结局
- HSC Yield in Apheresis Product(Up to 2 days)
- Adverse Events Experienced by Donors(Baseline though day 180)
- Graft Durability(Day 28)
- Graft-versus Host Disease (GVHD)(Day 100)
- Treatment-related Mortality(Day 100)
- Overall Survival(Day 100)
研究者
研究点 (8)
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