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

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05282719
Phase
PHASE2
Status
Unknown

Conditions

  • Adult
  • Myelodysplastic/Myeloproliferative Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • venetoclax combined with azacitidine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2022
Status verified
Mar 2022
Primary completion
Aug 31, 2022
Completion
Feb 28, 2023

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 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.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Study start date to study end date, or death, whichever comes first, up to 4 years ]

Related Studies