Status:
UNKNOWN
Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Myelodysplastic/Myeloproliferative Neoplasms
Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 patien...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Male or female, Age (years) \>= 18；
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
- Liver function: Total bilirubin ≤3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3 ULN; alanine aminotransferase (ALT)≤3 ULN；
- Renal function#Ccr ≥30 ml/min;
- 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
- Acute myeloid leukemia
- Myelodysplastic syndrome
- Subjects who had previously been treated with Venetoclax
- Subjects who are known to be allergic to ingredients of the study drug or their analogues
- HIV infection
- HBV-DNA or HCV-RNA positive
- Subjects with grade 2 or above cardiac failure and those considered unsuitable for inclusion by the investigator
- Subjects who are pregnant or breastfeeding
- Subjects reject to participate in the study
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05282719
Start Date
April 1 2022
End Date
February 1 2023
Last Update
March 16 2022
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, China, 215000