VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
- Sponsor
- The First Affiliated Hospital of Xiamen University
- Study ID
- NCT05603884
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- AML Stage, Adult
- Leukemia, Myeloid, Acute
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Venetoclax Combining Chidamide and Azacitidine (VCA) regimen followed by dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen — DRUGvenetoclax combining chidamide and azacitidine (VCA) 28 days per cycle × 2 cycles; 1) chidamide 30mg biw × 2weeks;2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7 dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen 28 days per cycle ×2 cycles; 1)dicitabine 25mg d1-3,2)liposome mitoxantrone 20mg d4,3)cytarabine 10mg/m2 Q12h d1-7 4)G-CSF 300ug d-1 until WBC \> 20×109/L
Study Details
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Key Dates
- Start date
- Dec 1, 2022
- Status verified
- Feb 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 66 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: treatment arm2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens, and then repeat the above four courses of treatment once
Primary Outcome Measure
Complete remission (CR) rate [ Time Frame: 6 months ]
Central Contacts
- Bing Xu, M.D.+865922137255
- Zhifeng Li+8613606901162
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