EUCTR2020-003669-21-IT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 syndromes (MDS) as per IPSS-R criteria - STIMULUS-AML1
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 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,
- •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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