2024-517959-12-00招募中2 期
An open label, phase I/II study of Venetoclax in addition to Blinatumomab immunotherapy in adult patients with relapsed/refractory B cell precursor acute lymphoblastic leukemia (BCP-ALL)
Goethe University Frankfurt18 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年11月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 18
- 主要终点
- Phase I: Maximum tolerated dose (MTD) Phase II: mol-CR rate in patients with CR/CRh/CRi as assessed by molecular MRD analyses of bone marrow cells obtained after one treatment cycle
研究概览
简要总结
Phase I: determination of feasibility, safety and tolerability and maximum tolerated dose of Venetoclax in combination with Blinatumomab. Phase II: to evaluate the response in patients treated with the combination of Venetoclax and Blinatumomab
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Written informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- •Availability of patient-specific molecular MRD markers of immunoglobulin/T-cell receptor gene rearrangements as assessed with a sensitivity of at least 10E-04
- •Diagnosis of Ph-negative, CD19-positive B-precursor acute lymphoblastic leukemia according to WHO classification: − Refractory BCP-ALL to primary induction therapy, including at least three cycles of standard chemotherapy − Untreated first relapse of BCP-ALL with first remission duration < 12 months or − Second or greater relapse of BCP-ALL or refractory relapse or − Relapse of BCP-ALL any time after allogeneic HSCT or
- •Positivity of MRD marker of immunoglobulin/T-cell receptor gene rearrangements of greater than 0.01% if in first or second remission of BCP-ALL
- •Negative pregnancy test < 7 days before first study drug in women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they fulfil at least one of the following criteria: − Post-menopausal (i.e. 12 months of natural amenorrhea or 6 months of amenorrhea with Serum FSH > 40 U/ml − Post-operative after bilateral ovariectomy with or without hysterectomy − Continuous and correct application of a contraception method with a Pearl index of < 1% (e.g. implants, depots, oral contraceptives, intrauterine device) from initial study drug administration until at least 3 months after the last dose of study drug. A hormonal contraception method must always be combined with a barrier method (e.g. condom) − Sexual abstinence − Vasectomy of the sexual partner
- •Ability to understand and willingness to sign a written informed consent
- •Willingness to participate in the registry of the German Multicenter Study Group for Adult ALL (GMALL)
排除标准
- •Patients with diagnosis of Philadelphia positive BCP-ALL according to WHO classification
- •Treatment with any of the following within 7 days prior to the first dose of study drug: strong cytochrome P450 3A (CYP3A) inhibitors, moderate or strong CYP3A inducers
- •Patients with diagnosis of Burkitt´s Leukemia according to WHO classification
- •Patients with extramedullary relapse; non-bulky lymph node (< 7.5 cm diameter) involvement will be accepted
- •Patients with CNS involvement at relapse (as determined by CSF analysis)
- •Patients with suspected or histologically confirmed testicular involvement at relapse
- •Current autoimmune disease of any kind or history of autoimmune disease with potential CNS involvement
- •Patients with Philadelphia-positive BCP-ALL still receiving TKI
- •Prior or concomitant therapy with BH3 mimetics
- •Prior therapy with anti CD19 therapy, unless administered in MRD-positive setting (i.e. with bone marrow blasts ≤ 5%)
结局指标
主要结局
Phase I: Maximum tolerated dose (MTD) Phase II: mol-CR rate in patients with CR/CRh/CRi as assessed by molecular MRD analyses of bone marrow cells obtained after one treatment cycle
Phase I: Maximum tolerated dose (MTD) Phase II: mol-CR rate in patients with CR/CRh/CRi as assessed by molecular MRD analyses of bone marrow cells obtained after one treatment cycle
次要结局
未报告次要终点
研究者
GMALL Studienzentrale
Scientific
Goethe University Frankfurt
研究点 (18)
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