Cirmtuzumab Consolidation for Treatment of Patients With Detectable CLL on Venetoclax
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Cancer response to treatment
研究概览
简要总结
Single center, open-label, phase 2 study to determine the efficacy of cirmtuzumab consolidation in patients with measurable disease on venetoclax.
详细描述
This is a phase 2 study to test whether cirmtuzumab in combination with venetoclax given as consolidation therapy can decrease the number of cancer cells that may be left in the bone marrow or in the blood in patients who have been treated with venetoclax for at least one year. Consolidation therapy is given after initial cancer treatment to further reduce the number of cancer cells that may be left in the body. Cirmtuzumab, a monoclonal antibody that inhibits receptor tyrosine kinase like orphan receptor (ROR1) signaling and stemness, may be effective in reducing the risk of disease progression in patients with detectable minimal residual disease (MRD) after treatment with venetoclax.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have detectable CLL/SLL (> 0.01% leukemia cells present)
- •Must have received at least 12 months of venetoclax.
- •Patients may be receiving venetoclax at the time of screening and study entry.
- •Patients who have discontinued venetoclax more than 6 months prior to study entry must still have a disease burden meeting criteria for low risk of TLS (i.e. no lymph node greater than 5 cm in diameter; absolute lymphocyte count less than 25 k/uL)
排除标准
- •Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- •Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- •Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
- •Child class B or C cirrhosis
- •Treatment with any of the following within 7 days prior to the first dose of cirmtuzumab:
- •Steroid therapy for anti-neoplastic intent
- •Biologic agent (monoclonal antibody) within 30 days for anti-neoplastic intent.
- •Chemotherapy (purine analog or alkylating agent) or target small molecule agent within 14 days or 5 half-lives (whichever is shorter), or has not recovered to less than CTCAE grade 2 clinically significant adverse effect(s)/toxicity(s) of previous therapy.
- •CLL therapy, aside from venetoclax.
- •History of other malignancy that could affect compliance with the protocol or interpretation of results (example: patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible.)
- •Women who are pregnant or lactating
研究组 & 干预措施
Cirmtuzumab + Venetoclax
All patients will receive a minimum of 6 cycles (cycle = 28 days) of therapy with venetoclax and cirmtuzumab during the treatment period. For patients who achieve undetectable minimal residual disease (uMRD) positive after cycle 6, an additional 6 cycles of venetoclax and cirmtuzumab may be administered.
干预措施: Cirmtuzumab (Drug)
Cirmtuzumab + Venetoclax
All patients will receive a minimum of 6 cycles (cycle = 28 days) of therapy with venetoclax and cirmtuzumab during the treatment period. For patients who achieve undetectable minimal residual disease (uMRD) positive after cycle 6, an additional 6 cycles of venetoclax and cirmtuzumab may be administered.
干预措施: Venetoclax (Drug)
结局指标
主要结局
Cancer response to treatment
时间窗: 6-24 months
Percentage of subjects with undetectable measurable residual disease after 6 months of cirmtuzumab + venetoclax treatment.
次要结局
- Frequency of adverse events(9-15 months)
- Time to next CLL treatment.(9-24 months)
研究者
Michael Choi
Associate Clin Professor
University of California, San Diego