NCT02765997撤回2 期
Single-Center, Open Label, Randomized Trial Comparing StemRegenin-1 Expanded Versus Unmanipulated Umbilical Cord Blood Transplantation In Patients With High-Risk Malignancy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Neutrophil Recovery
研究概览
简要总结
This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm.
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
- None
入排标准
- 年龄范围
- 2 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose >2.5 x 107 per kilogram recipient weight. HLA matching is initially based on 4 of 6 HLA-A and B (at low or intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing).
- •Eligible Diseases
- •Acute myelogenous leukemia (AML) at the following stages:
- •Intermediate to high risk leukemia in first complete remission (CR1) based on institutional criteria.
- •Any second or subsequent CR.
- •Secondary AML with prior malignancy that has been in remission for at least 12 months.
- •Acute lymphocytic leukemia (ALL) at the following stages:
- •High risk first remission.
- •Ph+ ALL, or
- •MLL rearrangement with slow early response at Day 14, or
- •Hypodiploidy (< 44 chromosomes or DNA index < 0.81), or
- •End of induction M3 bone marrow, or
- •End of induction M2 with M2-3 at Day
- •High risk second CR based on institutional criteria (eg, for children, bone marrow relapse <36 months from induction or T-lineage bone marrow relapse or very early isolated central nervous system (CNS) relapse <6 months from diagnosis, or slow re-induction (stage M2-3 at day 28 after induction) regardless of length remission.
- •Any third or subsequent CR.
- •Biphenotypic/undifferentiated leukemia in CR
- •Chronic myelogenous leukemia (CML) excluding refractory blast crisis
- •Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia
- •Other Inclusion Criteria
- •Karnofsky score >70% (16 years and older) or a Lansky play score >70 (children <16 years) - appendix II
- •Adequate organ function defined as:
- •Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, then renal function (creatinine clearance or GFR) >70 mL/min/1.73 m
- •Hepatic: Bilirubin ≤2.5 x mg/dL; AST, ALT, alkaline phosphatase <5 x upper limit of normal,
- •Pulmonary function: DLCO, FEV1, FEC (diffusion capacity) >50% of predicted (corrected for hemoglobin); if unable to perform pulmonary function tests, then normal O2 saturation on room air.
- •Cardiac: Left ventricular ejection fraction at rest must be >45%
- •Available 'back-up' HSPC graft (e.g, second partially HLA matched UCB unit, haploidentical related donor).
- •Voluntary written consent signed (adult or parental) before performance of any study-related procedure not part of normal medical care
排除标准
- •Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Females of childbearing potential must have a blood test or urine study within 14 days prior to study enrollment to rule out pregnancy.
- •Evidence of human immunodeficiency virus (HIV) infection or known HIV positive serology.
- •Active bacterial, viral or fungal infection (currently taking medication and progression of clinical symptoms).
- •Prior autologous or allogeneic transplant within past 12 months.
- •Other active malignancy.
- •Inability to receive TBI 1320 cGy (e.g., extensive prior therapy including >12 months alkylator therapy or >6 months alkylator therapy with extensive radiation. Or prior Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy.
研究组 & 干预措施
Unmanipulated UCB
Active Comparator
Subjects will receive unmanipulated umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.
干预措施: Unmanipulated UCB (Biological)
StemRegenin-1 UCB
Experimental
Subjects will receive StemRegenin-1 (SR-1) cultured umbilical cord blood transplantation after a myeloablative CY/FLU/TBI conditioning.
干预措施: SR-1 UCB (Biological)
结局指标
主要结局
Neutrophil Recovery
时间窗: Day 14 after transplantation
Percentage of patients with neutrophil recovery
次要结局
- Secondary Graft Failure(Day 100 after transplantation)
- Platelet Recovery(Day 100 after transplantation)
- Transplant-Related Mortality(6 months after transplantation)
研究者
研究点 (2)
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