JPRN-jRCT2051210150进行中（未招募）1 期
[M20-866] A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination with Venetoclax and/or Azacitidine in Subjects with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Satomi Natsuko0 个研究点目标入组 80 人开始时间: 2022年1月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Documented confirmation of acute myeloid leukemia (AML) according to the World Health Organization (WHO) criteria, previously untreated [OR]
- •- Documented diagnosis of previously untreated de novo myelodysplastic syndrome (MDS) according to the 2017 WHO classification with presence of < 20% bone marrow blasts per marrow biopsy/aspirate.
- •- Participants with documented MDS must meet the following disease activity criteria:
- •-- Overall revised international prognostic scoring system (IPSS-R) score > 3 (intermediate, high, or very high);
- •-- Eastern cooperative oncology group (ECOG) performance status of 0 to 2;
- •-- Hematopoietic stem cell transplant (HSCT) ineligible, or participant who chooses not to undergo HSCT.
- •- Participants with documented AML with adverse cytogenetic and/or molecular risk, and must be considered ineligible for induction therapy defined by the following:
- •-- >= 75 years of age; [OR]
- •-- >= 18 to 74 years of age with at least one of the following comorbidities:
- •--- Eastern cooperative oncology group (ECOG) performance status of 2 to 3;
- •--- Cardiac history of congestive heart failure requiring treatment or ejection fraction <= 50% or chronic stable angina;
- •--- Diffusion capacity of lung (DLCO) <= 65% or forced expiratory volume during the first second (FEV1) <= 65%;
- •--- Creatinine clearance >= 30 mL/min to < 45 mL/min;
- •--- Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 x upper limit of normal (ULN);
- •--- Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy or the participant declines to receive intensive chemotherapy.
- •Japan Safety Lead-In Phase:
- •- Documented confirmation of AML according to WHO criteria, relapsed or refractory (R/R) disease without other standard of care treatments.
- •- Documented diagnosis of MDS according to the 2017 WHO classification with presence of < 20% bone marrow blasts per marrow biopsy/aspirate, with intermediate- and high-risk relapsed/refractory MDS.
- •- Documented MDS must meet the following disease activity criteria:
- •-- ECOG performance status of 0 to 2.
排除标准
- •- Participants with documented AML with acute promyelocytic leukemia and considered eligible for induction therapy.
- •- Participant with documented AML having prior diagnosis of:
- •-- Chronic myeloid leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation;
- •-- known active central nervous system involvement with AML.
- •- Participants with documented MDS having prior diagnosis of:
- •-- Therapy-related MDS;
- •-- MDS evolving from a pre-existing myeloproliferative neoplasm (MPN);
- •-- MDS/MPN including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, juvenile myelomonocytic leukemia and unclassifiable MDS/MPN.
- •- History of allogeneic HSCT or solid organ transplantation.
- •- Previous exposure to azacitidine or venetoclax or anti-CD47 therapies.
- •- History of an active malignancy within the past 2 years prior to Screening, with the exception of:
- •-- Adequately treated carcinoma in situ of the cervix uteri or carcinoma in situ of the breast;
- •-- Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin;
- •-- Asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy;
- •-- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- •- Conditions that could interfere with drug absorption including but not limited to short bowel syndrome.
- •Japan Safety Lead-In Phase:
- •- Documented AML have Acute Promyelocytic Leukemia.
- •- Participant with documented AML having prior diagnosis of:
- •-- Chronic myeloid leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- •- Participants with documented MDS having prior diagnosis of:
- •-- Therapy-related MDS.
研究者
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