EUCTR2020-003669-21-GR进行中（未招募）1 期
A single-arm, open-label, Phase II study of sabatolimab in combination with azacitidine and venetoclax in adult participants with high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R criteria
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent must be obtained prior to participation in the study
- •2. Age = 18 years at the date of signing the informed consent form (ICF)
- •3. Morphologically confirmed diagnosis of myelodysplastic syndrome (MDS)
- •based on 2016 WHO classification by local investigator assessment with one of the following Prognostic Risk Categories, based on the revised International Prognostic Scoring System (IPSS-R):
- •? Very high (> 6 points)
- •? High (> 4.5-6 points)
- •4. Not immediately eligible for hematopoietic stem-cell transplantation (HSCT) or intensive chemotherapy at the time of screening due to individual clinical factors such as age, comorbidities and performance status, donor availability
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •Additional inclusion criteria as per full protocol may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 53
排除标准
- •1. Prior exposure to TIM-3 directed therapy or any BCL-2 inhibitor (including
- •venetoclax) at any time
- •2. Prior therapy with immune check point inhibitors (e.g. anti-CTLA4, anti-
- •PD-1, anti-PD-L1, or anti-PD-L2) or cancer vaccines is not allowed if the last
- •dose of the drug was administered within 4 months prior to start of treatment
- •3. Previous first-line treatment for very high risk or high risk myelodysplastic syndromes (based on IPSS-R) with any antineoplastic agents, approved or
- •investigational, including for example chemotherapy, lenalidomide and
- •hypomethylating agents (HMAs) such as decitabine or azacitidine. However, a one single cycle of HMAs treatment only started prior to enrollment is allowed.
- •4. Live vaccine administered within 30 days prior to start of treatment
- •5. Current use or use within 14 days prior to start of treatment of systemic
- •steroid therapy (> 10 mg/day prednisone or equivalent) or any
- •immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are
- •allowed. Replacement therapy, steroids given in the context of a transfusion,
- •are allowed and not considered a form of systemic treatment
- •6. History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or sabatolimab) or monoclonal antibodies (mAbs) and/or their excipients
- •7. Participants with Myelodysplastic syndrome (MDS) based on 2016 WHO
- •classification with revised International Prognostic Scoring System (IPSS-R) = 4.5
- •Other protocol-defined Inclusion/Exclusion may apply.
研究者
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