ACTRN12619000079145尚未招募1 期
A Phase I Study of Autologous CD19 Specific Chimeric Antigen Receptor T-cells for Therapy of Relapsed and Refractory B-cell Leukaemia and Lymphoma
Western Sydney Local Health District, Westmead Hospital0 个研究点目标入组 20 人开始时间: 2019年1月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •1. Any patient regardless of sex or age with relapsed or refractory disease after standard therapy. Disease may be identified by clinical examination, radiology, nuclear imaging, flow cytometry or molecular biological methods. To qualify for enrolment, patients must have one of the following:
- •-Refractory CD19+ high grade NHL- defined as less than 50% reduction in lymph node size (nodes >2cm) or persisting organ enlargement or the appearance of new lymphadenopathy, hepatosplenomegaly or marrow involvement after chemotherapy or Deauville 5 PET positive disease on interim PET scan after 4 cycles of chemotherapy
- •- Relapsed CD19+ high grade NHL ineligible for autologous stem cell transplant or after autologous stem cell transplant
- •-Refractory CD19+ low grade NHL- defined as less than 50% reduction in lymph node size (nodes >2cm) or persisting organ enlargement or the appearance of new lymphadenopathy, hepatosplenomegaly or marrow involvement after chemotherapy
- •-Relapsed CD19+ low grade NHL less than 12 months from chemotherapy or third or greater relapse
- •-Refractory CLL defined as resistance to purine analogues with less than 50% reduction in lymph node size (nodes >2cm) and/or lymphocytosis, or persisting organ enlargement after initial therapy or progression/relapse requiring therapy less than 6 months post chemotherapy.
- •-CLL Richters transformation
- •-Persistent CD19+ ALL after consolidation, defined as not in CR by morphology, flow, cytogenetics or molecular methods after induction chemotherapy (includes MRD at or above threshold as assessed by flow cytometry or molecular methods)
- •-Relapsed CD19+ ALL as assessed by morphology, flow, cytogenetics or molecular methods at any time point during or after standard therapy
- •2. Karnofsky/Lansky score greater than or equal to 50%, or ECOG less than or equal to 2.
- •3. Sexually active patients must be willing to utilise one of the more effective birth control methods for 6 months after the CTL infusion. Male partners should use a condom.
- •4. Patient and/or parent/guardian capable of providing informed consent.
排除标准
- •1. Uncontrolled inter-current infection.
- •2. Bilirubin >2x upper limit of normal, AST >3x upper limit of normal, creatinine >2x upper limit of normal for age.
- •3. Pulse oximetry greater than or equal to 90% on room air.
- •4. Pregnant or lactating.
- •5. History of hypersensitivity reactions to murine protein-containing products.
- •6. History of seizures.
研究者
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