Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML (RAVEN)
This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML.
People with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects.
The study has two parts:
- Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission.
- Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs.
Patients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Lauren Higgins
- 电话号码：919-984-0000
- 邮箱：Lauren_Higgins@med.unc.edu
学习地点
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
接触：
- Lauren Higgins
- 电话号码：919-984-0000
- 邮箱：Lauren_Higgins@med.unc.edu
-
首席研究员：
- Joshua Zeidner
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age 18-65 years at the time of consent.
- Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics/karyotype or FISH
Exclusion Criteria:
- Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study)
- Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry.
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)
Patients with KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML) did not receive a treatment.
|
Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.
Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.
Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete remission rate
大体时间：Up to 3 months
|
Complete remission (CR) rate will be determined as defined in the protocol Response Criteria.
Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC > 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)
|
Up to 3 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Composite Complete remission
大体时间：Up to 3 months
|
Composite Complete remission (CCr) rate defined as complete remission (CR) + complete remission with incomplete recovery (CRi) + complete remission with partial hematologic recovery (CCr)= CR + CRi + CRh. CR: Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC > 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL) CRi = All CR criteria except for residual neutropenia <1.0 × 109/L (1,000/μL) or thrombocytopenia < 100× 109/L (100 000/μL CRh: ANC ≥ 0.5 × 109/L (500/μL) and platelet count ≥50 × 109/L (50 000/μL), otherwise all other CR criteria met. |
Up to 3 months
|
|
Duration of complete remission (DOCR)
大体时间：Up to 2 years
|
Duration of complete remission (DOCR) will be defined as the time from the first complete remission to hematological relapse or death from any cause.
CR: Bone marrow blasts < 5%; absence of circulating blasts; absence of extramedullary disease; ANC > 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)
|
Up to 2 years
|
|
Event-free survival
大体时间：Up to 2 years
|
Event-free survival will be determined as time until treatment failure (lack of CRc), relapse or death.
|
Up to 2 years
|
|
The number of treatment-emergent adverse events
大体时间：Up to 2 years
|
The number of treatment-emergent special interest (AESIs) and serious adverse events (SAEs), and clinically significant test results will be submitted.
|
Up to 2 years
|
|
Relapse-free survival
大体时间：Up to 2 years
|
Relapse-free survival will be determined as time to relapse or death after achieving CR.
|
Up to 2 years
|
|
Overall survival
大体时间：Up to 2 years
|
Overall survival will be determined as time until date of death from any cause.
|
Up to 2 years
|
|
MRD-Negative (MRD<0.02%) complete remission
大体时间：Up to 3 months
|
MRD-Negative (MRD<0.02%)
complete remission rate will be assessed from bone marrow samples using Hematologics Flow MRD assay after 2 cycles of RAVEN treatment
|
Up to 3 months
|
合作者和调查者
调查人员
- 首席研究员：Joshua Zeidner, MD、UNC Lineberger Comprehensive Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.