A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination with Venetoclax and Azacitidine in Adult Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 42
- 主要终点
- Phase 2: Complete remission (CR)
研究概览
简要总结
Phase 2: To evaluate if treatment with pivekimab sunirine (PVEK) in combination with venetoclax (VEN) + azacitadine (AZA) improves complete remission (CR) rate as compared to standard of care with VEN + AZA in adult participants with newly diagnosed acute myeloid leukemia (AML) ineligible to receive intensive chemotherapy.
Phase 3: To assess the superiority of treatment with PVEK in combination with VEN + AZA in improving CR rate and prolonging overall survival (OS) compared to standard of care VEN + AZA in adult participants with newly diagnosed AML ineligible to receive intensive chemotherapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must have confirmation of acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organization (WHO) criteria.
- •White blood cell (WBC) count < 25 × 10^9/L (hydroxyurea is permitted prior to beginning study treatment to reduce the WBC count to < 25 × 10^9/L).
- •Adequate renal function as demonstrated by a creatinine clearance >= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.
排除标准
- •Acute promyelocytic leukemia (APL), blast phase of CML or AML with t(9;22) or BCR:ABL1 fusion, transformation from myeloproliferative neoplasm (MPN), Chronic Myelomonocytic Leukemia (CMML), myelodysplastic/myeloproliferative neoplasm unspecified, or myeloid sarcoma.
- •Known active central nervous system (CNS) involvement with AML. Participants may have non-CNS extramedullary disease (excludes participants with myeloid sarcoma as the only disease manifestation at screening).
- •Participants with history of any malignancies within 2 years prior to screening with exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of the breast, in situ - carcinomas of bladder and esophagus; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, and previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and have no evidence of relapse within 2 years.
研究组 & 干预措施
Venetoclax, Venetoclax, Venetoclax
干预措施: Venetoclax (Drug)
PIVEKIMAB SUNIRINE
干预措施: PIVEKIMAB SUNIRINE (Drug)
AZACITIDINE
干预措施: AZACITIDINE (Drug)
结局指标
主要结局
Phase 2: Complete remission (CR)
Phase 2: Complete remission (CR)
Phase 3: Complete remission (CR)
Phase 3: Complete remission (CR)
Phase 3: Overall Survival (OS)
Phase 3: Overall Survival (OS)
Number of Participants with Adverse Events (AEs)
Number of Participants with Adverse Events (AEs)
次要结局
- Phase 2 and Phase 3: Composite Response
- Phase 2 and Phase 3: Duration of CR (DoCR)
- Phase 3: Change from Baseline to the responses to FACT GP5
- Phase 2: Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ-C30) domains
- Phase 3: Percentage of Participants with Transfusion Independence
- Phase 3: Conversion from baseline transfusion dependence to post-baseline transfusion independence
- Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domains
- Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains
- Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Utility Index and Visual Analog Scale (VAS) scores
研究者
Global Clinical TrialsHelpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG