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Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults

2022年3月7日 更新者：Chen Suning、The First Affiliated Hospital of Soochow University

A Multi-center, Phase II, Single-arm Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults

To explore the efficacy of venetoclax combined with azacytidine in Myelodysplastic / myeloproliferative neoplasms（MDS/MPN）, so as to improve the overall survival and treatment status of MDS/MPN patients.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

At present, there is no standardized treatment strategy for MDS/MPN. The purpose of our study is to explore the efficacy of venetoclax combined with azacytidine in the treatment of MDS/MPN, so as to improve the overall survival and treatment status of patients with MDS/MPN. After the participants were treated with four cycles of venetoclax combined with azacytidine, the efficacy was evaluated according to the 2015 adult MDS/MPN response criteria to determine the disease status. Participants with disease progression and intolerance withdrew from the study during treatment.

研究类型

介入性

注册 (预期的)

33

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Jiangsu
      • Suzhou、Jiangsu、中国、215000
        • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Male or female, Age (years) >= 18；

  2. Patients newly diagnosed or previously treated with MDS/MPNs (CMML, MDS/MPN-U, aCML) according to 2016 WHO diagnostic criteria:

    Initial diagnosis: CMML: CPSS-mol intermediate risk 2 and above; aCML; MDS/MPN-U.

    Previous treatment: HMA treatment failed.

  3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
  4. Liver function: Total bilirubin ≤3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3 ULN; alanine aminotransferase (ALT)≤3 ULN；
  5. Renal function#Ccr ≥30 ml/min;
  6. Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.

Exclusion Criteria:

  1. Acute myeloid leukemia
  2. Myelodysplastic syndrome
  3. Subjects who had previously been treated with Venetoclax
  4. Subjects who are known to be allergic to ingredients of the study drug or their analogues
  5. HIV infection
  6. HBV-DNA or HCV-RNA positive
  7. Subjects with grade 2 or above cardiac failure and those considered unsuitable for inclusion by the investigator
  8. Subjects who are pregnant or breastfeeding
  9. Subjects reject to participate in the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 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：Treatment regime
On day 1 of each cycle, decitabine 75 mg/m2 will be given subcutaneously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 14 day cycle is finished.
药品：venetoclax combined with azacitidine
On day 1 of each cycle, decitabine 75 mg/m2 will be given subcutaneously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 14 day cycle is finished.
其他名称：
  • combination of venetoclax plus azacitidine

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
Overall Response Rate (ORR)
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years

ORR (equals the rates of complete remission [CR]+partial remission [PR]+complete cytogenetic remission [CCyR]+marrow response [MR[+clinical benefit [CB] )of venetoclax in combination with azacitidine.

  1. CR and CCyR are shown in the secondary outcome measures below.
  2. PR: Normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts (and blast equivalents) reduced by 50%, but remaining>5% of cellularity except in cases of MDS/MPN with≤5% bone marrow blasts at baseline.

  3. MR: Optimal marrow response: Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices.

    Partial marrow response: Bone marrow blasts (and blast equivalents) reduced by 50%, but remaining>5% of cellularity, or reduction in grading of reticulin fibrosis from baseline on at least 2 bone marrow evaluations spaced at least 2 months apart.

  4. CB: Hematology improvement, spleen response and symptom response.
Study start date to study end date, or death, whichever comes first, up to 4 years

次要结果测量

结果测量
措施说明
大体时间
Complete remission rate
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years
  1. Bone marrow: ≤5% myeloblasts (including monocytic blast equivalent in case of CMML) with normal maturation of all cell lines and return to normal cellularity Osteomyelofibrosis absent or equal to "mild reticulin fibrosis" (≤grade 1 fibrosis).
  2. Peripheral blood: Leukocyte≤10×10E9 cells/L; Hemoglobin≥11g/dL; Platelets≥100×10E9/L, ≤450×10E9/L; Neutrophils≥1.0×10E9/L; Blasts 0%; Neutrophil precursors reduced to≤2%; Monocytes ≤1.0× 10E9/L.
  3. Extramedullary disease: Complete resolution of extramedullary disease present before therapy (eg, cutaneous disease, disease-related serous effusions), including palpable hepatosplenomegaly.
Study start date to study end date, or death, whichever comes first, up to 4 years
Complete remission rate of bone marrow morphology
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years
Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices as presented above.
Study start date to study end date, or death, whichever comes first, up to 4 years
Hematology improvement (HI) rate
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years

Percentages of participants with HI (erythroid/platelet/neutrophil responses)

  1. Erythroid response: Hemoglobin increase by≥2.0 g/dL; Transfusion independence (TI) for ≥8 week for patients requiring at least 4 packed red blood cell transfusions in the previous 8 week; Only red blood cell transfusions given based on physician's judgment for a pretreatment Hgb of ≤8.5 g/dL will count in the red blood cell TI response evaluation.
  2. Platelet response: TI when previously requiring platelet transfusions of at least a rate of 4 platelet transfusions in the previous 8 week; Pretreatment≤20×10E9/L: increase from<20×10E9/L to>20×10E9/L and by at least 100%; Pretreatment>20×10E9/L but≤100×10E9/L: absolute increase of ≥30×10E9/L.
  3. Neutrophil response: Pretreatment≤0.5×10E9/L at least 100% increase and an absolute increase≥0.5×10E9/L; Pretreatment>0.5×10E9/L and≤1.0×10E9/L, at least 50% increase and an absolute increase ≥0.5×10E9/L.
Study start date to study end date, or death, whichever comes first, up to 4 years
Complete cytogenetic remission rate
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years
Resolution of previously present chromosomal abnormality (known to be associated with myelodysplastic, syndrome myeloproliferative neoplasms, or MDS/MPN), as seen on classic karyotyping with minimal of 20 metaphases or FISH.
Study start date to study end date, or death, whichever comes first, up to 4 years
Incidence of severe infection (≥grade 3 )
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years
Assessed using CTCAE 5
Study start date to study end date, or death, whichever comes first, up to 4 years
Spleen response rate
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years
Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable.
Study start date to study end date, or death, whichever comes first, up to 4 years
Symptom response rate
大体时间：Study start date to study end date, or death, whichever comes first, up to 4 years
Improvement in symptoms as noted by decrease of ≥50% as per the MPN-SAF TSS scoring<20 were not considered eligible for measuring clinical benefit.
Study start date to study end date, or death, whichever comes first, up to 4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The First Affiliated Hospital of Soochow University

调查人员

  • 首席研究员：Suning Chen, Professor、The First Affiliated Hospital of Soochow University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年4月1日

初级完成 (预期的)

2022年8月1日

研究完成 (预期的)

2023年2月1日

研究注册日期

首次提交

2022年2月21日

首先提交符合 QC 标准的

2022年3月7日

首次发布 (实际的)

2022年3月16日

研究记录更新

最后更新发布 (实际的)

2022年3月16日

上次提交的符合 QC 标准的更新

2022年3月7日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MDS/MPN-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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.

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