Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 1\) Histologically confirmed acute myeloid leukemia (non-M3). Treatment-na?ve and unable to receive standard cytarabine and anthracycline induction regimens due to age or comorbidities or patient preference.

• 2\) Age ≥ 60 years old, male or female, with an expected survival more than 3 months.

• 3\) Estimated creatinine clearance ≥ 30 mL/min. 4) AST and ALT ≤ 3.0 x ULN (unless leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement).

• 5\) ECOG ≤ 2. 6) Able to understand and voluntarily provide informed consent.

Locations
Other Locations
China
Bing Xu
RECRUITING
Xiamen
Contact Information
Primary
Bing Xu, M.D.
xubingzhangjian@126.com
+865922137255
Backup
Zhifeng Li
lzf_xm@163.com
+8613606901162
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 66
Treatments
Experimental: treatment arm
2 cycles of VCA regimens followed by 2 cycles of D-MAG regimens, and then repeat the above four courses of treatment once
Related Therapeutic Areas
Sponsors
Collaborators: Fujian Provincial Hospital, Zhangzhou manicipal hospital of Fujian Province, Huizhou Municipal Central Hospital, Chipscreen Biosciences, Ltd., CSPC Pharmaceutical Group Limited, Fujian Cancer Hospital, Jieyang People's Hospital
Leads: The First Affiliated Hospital of Xiamen University

This content was sourced from clinicaltrials.gov

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