Overview

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

Status:
Enrolling by invitation

Trial end date:
2023-02-01

Target enrollment:
0

Participant gender:
All

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 patients.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The First Affiliated Hospital of Soochow University

Treatments:

Azacitidine
Venetoclax

Criteria

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