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Trial Title:
VAC Regimen for AML Patients Who Failed to Response to VA Regimen
NCT ID:
NCT06220162
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Conditions: Keywords:
AML venetoclax azacitidine chidamide unfit
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:
chidamide in combination with venetoclax and azacitidine (VAC)
Description:
Enrolled patients were given chidamide 10 mg every day on days 1-14, azacitidine 75mg/m2
every day on days 1-7, and oral venetoclax began at 100mg on day 1 and increased stepwise
over 3 days to reach the target dose of 400mg (100mg, 200mg, and 400mg) on days 1-28.
Dose adjustments for concomitant venetoclax with CYP3A4 inhibitors were made according to
the literature.
Arm group label:
VAC regimen
Summary:
Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve
remission rate of patients following to VA regimen treatment failure.
Detailed description:
Venetoclax and azacitidine has become the standard first-line treatment for
elderly/unsuitable AML patients who can't tolerate for intense chemotherapy.
However, a proportion of patients who were not able to achieve remission after failing to
VA regimen and then were given the second cycle, and their rate of achieving remission
was even lower. Chidamide down-regulates the expression of MCL and is expected to improve
the remission rate further in combination with VA regimen.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients with AML who are not suitable for intensive chemotherapy according to the WHO
diagnosis: age ≥60 years or age <60 years but fulfil the following criteria;
1. Age 18 to 59 years;
2. Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
3. Expected survival time ≥3 months;
4. Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence
of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or
presence of chronic stable angina; (B) Lung carbon monoxide diffusing capacity
(DLCO) ≤ 65%, or first forced expiratory volume (FEV1) ≤ 65%; (C) Moderate hepatic
impairment with total bilirubin > 1.5 to ≤ 3.0 x upper limit of normal (ULN); (D)
Creatinine clearance ≥ 30 mL/min to < 45 mL/min;
5. Not received radiotherapy, treatment regimens other than the VA regimen, or
haematopoietic stem cell transplantation within 4 weeks prior to enrolment;
6. Other comorbidities that, in the judgement of the physician, make the administration
of intensive chemotherapy unsuitable;
7. Ability to understand and willingness to sign the informed consent for this trial;
8. The patient refuses intensive chemotherapy and has the willingness to accept
non-intensive chemotherapy.
Exclusion Criteria:
1. Patients with a history of myeloproliferative neoplasms (MPN), including
myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia
(CML) with or without BCR-ABL1 translocation, and AML or acute promyelocytic
leukemia (APL) with BCR-ABL1 translocation;
2. Patients with FLT3 mutations and who were treated with targeted agents (inclusion is
possible if the use of specific targeted agents is discontinued);
3. Patients with less than 50% reduction of blasts after VA regimen;
4. Patients with active CNS involvement;
5. With prior treatment with chidamide;
6. Clinically uncontrolled active infections (including bacterial, fungal or viral
infections) and organ hemorrhage;
7. Pregnant or lactating women;
8. Participation in any other clinical trial within 3 months prior to VAC regimen;
9. With other malignant tumours;
10. With uncontrolled mental disorders;
11. Any other condition that, in the opinion of the investigator, makes it inappropriate
to participate in this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Sheng-Li N Xue, M.D.
Phone:
+8651267781139
Email:
slxue@suda.edu.cn
Start date:
February 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Jining Medical University
Agency class:
Other
Collaborator:
Agency:
The Second People's Hospital of Huai'an
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Bengbu Medical College
Agency class:
Other
Collaborator:
Agency:
Northern Jiangsu People's Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06220162
