NL-OMON55557已完成不适用
Phase 1b, multi-arm, open-label study of PDR001 and/or MBG453 in combination with decitabine in patients with acute myeloid leukemia or high risk myelodysplastic syndrome (CPDR001X2105) - PDR001 and/or MBG453 in combination with decitabine in AML or MDS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female patients * 18 years of age with
- •ARM 1-2-3 :
- •* Refractory/relapsed AML following *1 prior therapies
- •* De novo AML patients who are are suitable for treatment with decitabine
- •(patients who are suitable for standard induction chemotherapy and willing to
- •receive it are excluded)
- •* Intermediate or high risk MDS or MDS/MPN, including CMML
- •Arm 4a & 5a:
- •* Relapsed/refractory AML following *1 prior therapies who have relapsed or
- •exhibited refractory disease (primary failure)
- •Arm 4b & 5b:
- •* Intermediate or High risk MDS patients or MDS/MPN, including CMML who have
- •failed hypomethylating agent therapy.
- •* Newly diagnosed AML patients who are suitable for treatment with azacitidine
- •* Intermediate or high-risk MDS or MDS/MPN, including CMML
- •2. ECOG performance status 0-1-2
- •3. Candidate for serial bone marrow aspirate and/or biopsy according to the
- •institutions guidelines and be willing to undergo the planned bone marrow
- •aspirate and/biopsy according to protocol.
排除标准
- •1. Arms 1-2-3 or Arm 6 : Prior decitabine or hypomethylating agent treatment
- •for AML or MDS.
- •2. Impaired cardiac function or clinically significant cardiac disease. See
- •protocol page 32 for details.
- •3. HIV, active hepatitis B, C. See protocol page 32-33 for details.
- •4. Active, known or suspected autoimmune disease. See protocol page 33 for
- •5. History of, or current drug-induced interstitial lung disease or pneumonitis
- •grade * 2.
- •6. Patients who discontinued prior PD-1 or PD-L1 directed therapy due to a
- •treatment related toxicity should not be included in the PDR001 containing arms
- •of the study. See protocol page 33 for more details.
- •7. Patients who discontinued prior TIM-3 directed therapy due to a treatment
- •related toxicity should not be included in the TIM-3 containing arms of the
- •8. Treatment with cytotoxic or targeted antineoplastics within 3 weeks of
- •initiation of study treatment. See protocol page 33 for details.
- •9. Systemic chronic corticosteroid therapy (* 10 mg/day prednisone or
- •equivalent) or any immunosuppressive therapy within 7 days of first dose of
- •study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
- •10. Live vaccine against infectious disease within 4 weeks of study treatment.
- •11. Pregnancy, lactation, insufficient contraception for females of
- •childbearing potential and males.
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