NCT06915246招募中2 期
A Randomized Phase 2 Study of Carmustine Formulated With and Without Ethanol as Part of BEAM Chemotherapy Conditioning for Subjects With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation (AHCT)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- VIVUS LLC
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Evaluation of infusion-related toxicities
研究概览
简要总结
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months;
- •Karnofsky performance status ≥ 70%;
- •Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma;
- •Candidate for AHCT consolidation therapy as assessed by their treating physician;
- •Achieved a complete or partial response;
- •Completed collection of at least 2.0 x 10^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPCs) by apheresis;
- •Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2;
- •Clinical laboratory and organ function criteria meeting study ranges/limits LVEF ≥ 50%; FEV1 > 65% of predicted measurement, DLCO ≥ 50% of predicted;
- •Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis
排除标准
- •Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation;
- •Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records;
- •Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy;
- •Myelodysplasia or any active malignancy other than HL or NHL, or < 5 years remission from any other prior malignancy;
- •Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia;
- •Persistent marrow involvement (>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization;
- •Not having sufficient bone marrow harvest to reach adequate cell dose for transplant;
- •Active hepatitis B or C viral infection or HBsAg positive;
- •Positive HIV antibody;
研究组 & 干预措施
VI-0609
Experimental
VI-0609 (Carmustine with Propylene Glycol)
干预措施: VI-0609 (Drug)
BiCNU
Active Comparator
BiCNU (Carmustine with Ethanol)
干预措施: BiCNU (Drug)
结局指标
主要结局
Evaluation of infusion-related toxicities
时间窗: Within 24 hours post infusion
Evaluation of unacceptable toxicities
时间窗: From start of BEAM through Day 30 post-AHCT
次要结局
未报告次要终点
研究者
研究点 (4)
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