EUCTR2019-001545-41-DE进行中（未招募）1 期
A Phase 1/2 First in Human Study of the Menin-MLL(KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 236
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
- 性别
- All
入选标准
- •Key Inclusion Criteria:
- •1. Relapsed/refractory (R/R) acute myeloid leukemia (AML) defined as those who have also failed or are not appropriate for any approved standard-of-care (SOC) therapies or hematopoietic stem cell transplant (HSCT)with reappearance of = 5% blasts in the bone marrow (BM).
- •2. = 18 years of age.
- •3. Eastern Cooperative Oncology Group performance status of = 2, and a life expectancy of at least 2 months.
- •4. Peripheral white blood cell counts = 30,000/µL.
- •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 118
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 118
排除标准
- •Key Exclusion Criteria
- •1. Diagnosis of acute promyelocytic leukemia or chronic myelogenous leukemia in blast crisis.
- •2. Donor lymphocyte infusion < 30 days prior to study entry.
- •3. Clinically active central nervous system (CNS) leukemia.
- •4. Has undergone HSCT and have not had adequate hematologic recovery (Recovery is defined as peripheral absolute neutrophil count (ANC) = 1 × 10^9/L and platelets at least = 50 × 10^9/L [but preferably = 100 × 109/L] and signs of a cellular BM).
- •5. Patients on immunosuppressive therapy post HSCT must be off all immunosuppression therapy within 2 weeks of Cycle 1 Day 1.
- •6. = Grade 2 active GvHD, moderate or severe limited chronic GvHD, or extensive chronic GvHD of any severity.
- •7. Has received prior menin inhibitor
- •8. Has received chemotherapy, immunotherapy, radiotherapy (unless if given for management of CNS leukemia), or any ancillary therapy that is considered to be investigational (ie, used for non-approved indications(s) and in the context of a research investigation) < 14 days prior to the first dose of ziftomenib or within 5 drug half-lives prior to the first dose of study drug, whichever is shorter, to ensure that patient time without necessary AML therapy is appropriately limited.
- •9. Requires treatment with concomitant drugs that are strong inhibitors or inducers of CYP3A4 with the exception of antibiotics, antifungals, and antivirals that are used as SOC to prevent or treat infections. Other such drugs that are considered absolutely essential by the Investigator for the care of the patient should be discussed on a case-by-case basis with the Kura Medical Monitor.
- •10. Has an active uncontrolled acute or chronic systemic fungal, bacterial, viral, or other infection.
- •11. Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, history of cerebrovascular accident including transient ischemic attack within the past 6 months, congestive heart failure (New York Heart Association Class III or IV) related to primary cardiac disease, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the first dose of study treatment.
- •12. Mean corrected QT interval by Fredericia's formula > 480 ms on triplicate electrocardiograms.
研究者
相似试验
招募中
1 期
A Phase 1/2 First in Human Study of the Menin-MLL (KMT2A) Inhibitor KO-539 in Patients with Relapsed or Refractory Acute Myeloid LeukemiaRelapsed and/or refractory Acute Myeloid LeukemiaMedDRA version: 21.0Level: LLTClassification code: 10060558Term: Acute myeloid leukemia recurrent Class: 10029104CTIS2023-510509-17-00Kura Oncology Inc.205
进行中（未招募）
1 期
First in human clinical trial of the study drug KO-539 in patients with leukemiaRelapsed and/or refractory Acute Myeloid LeukemiaMedDRA version: 21.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 100000004864EUCTR2019-001545-41-ITKURA ONCOLOGY INC90
进行中（未招募）
1 期
Study of Phase I/II of the combination of L19IL2 with Rituximab in Diffuse Large B-cell LymphomaRelapsed or refractory CD20+ diffuse large B-cell lymphoma (DLBCL) in patients who are ineligible for autologous stem cell transplantation or who relapse/progress after transplantation.MedDRA version: 17.0Level: LLTClassification code 10012907Term: Diffuse mixed small and large cell lymphoma (Diffuse large B-cell lymphoma) recurrentSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10012908Term: Diffuse mixed small and large cell lymphoma (Diffuse large B-cell lymphoma) refractorySystem Organ Class: 100000004864EUCTR2014-001949-25-DEPhilogen S.p.A.20
未知
1 期
Phase I, Multiple Dose Study of MLN0002 in Patients with Ulcerative Colitislcerative ColitisJPRN-jRCT2080221099Takeda Pharmaceutical Company Limited12
已完成
1 期
Safety and tolerability of MIL-38/ Gallium67 (MILGa) in patients with advanced prostate, bladder and pancreatic cancer.Prostate cancerPancreatic cancerBladder cancerACTRN12616000787482Minomic International12