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Trial Title:
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT ID:
NCT05603884
Condition:
Leukemia, Myeloid, Acute
AML Stage, Adult
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Venetoclax
Mitoxantrone
Conditions: Keywords:
newly diagnosed acute myeloid leukemia
liposome mitoxantrone
sequential treatment
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax Combining Chidamide and Azacitidine (VCA) regimen followed by dicitabine combined with liposome mitoxantrone, cytarabine, and G-CSF (D-MAG) regimen
Description:
venetoclax 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
Arm group label:
treatment arm
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)
Detailed description:
Elderly Patients with AML have inferior outcomes due to poor physical condition, and
intolerant to conventional chemotherapy. The regimen of Venetoclax and Azacitidine has
been widely used in these patients and has proved to achieve higher CR rate than low
intensity therapy. However, the median duration of response (DOR) of this regimen is
about one year. Chidamide is a histone deacetylase (HDAC) inhibitor and preclinical data
showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of
leukemia cell lines. The Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was
applied to one 62-year-old male patient with AML who achieved CR. Meanwhile, Liposome
mitoxantrone has better safety and tolerance than mitoxantrone in elderly patients. Thus,
this study is intended to use 2 cycles of VCA regimens followed by 2 cycles of D-MAG
regimens, and then repeat the above four courses of treatment once to improve the median
event free survival of elderly AML patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
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.
Exclusion Criteria:
- 1)Acute promyelocytic leukemia (APL) and low risk cytogenetics such as t(8;21),
inv(16) or t(16;16).
2) Active central nervous system leukemia. 3) History of myeloproliferative
neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia
vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and
AML with BCR- ABL1 translocation.
4) HIV positive patients and/or HBV or HCV active infection (documented by HBV-DNA
and HCV-RNA positive test) 5) Patients suffering from chronic respiratory
diseases that require continuous oxygen inhalation, or a history of obvious
renal, nervous system, psychiatric, endocrine, metabolic, immune, liver, and
cardiovascular diseases 6) Patients suffering from malabsorption syndrome or
other conditions that exclude enteral route of administration.
7) Patients has clinically significant QTc prolongation (>450 ms in men; >470 ms
in women), ventricular tachycardia and atrial fibrillation, second-degree heart
block, myocardial infarction within the year prior to enrollment, and
congestive heart failure;and patients with coronary heart disease with clinical
symptoms requiring drug treatment.
8) Active, uncontrolled severe infection. 9) History of other malignancies within
2 years, except for the following: Adequately treated cervix or breast cancer
in situ; Basal cell cancer or local squamous cell carcinoma of the skin; 10)
White blood cell count > 25 × 10^9/L. (Hydroxyurea or leukapheresis may meet
this criterion.) 11) Mental disorders that hinder research participation 12)
Participants have received the following treatments: hypomethylating agents,
veneclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ
transplantation.
13) Any other circumstances that the investigator believes that the patient is not
suitable to participate in this trial
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Bing Xu
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xu
Investigator:
Last name:
Bing Xu
Email:
Principal Investigator
Start date:
December 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
Chipscreen Biosciences, Ltd.
Agency class:
Industry
Collaborator:
Agency:
CSPC Pharmaceutical Group Limited
Agency class:
Industry
Collaborator:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Zhangzhou manicipal hospital of Fujian Province
Agency class:
Other
Collaborator:
Agency:
Jieyang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Huizhou Municipal Central Hospital
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05603884
