A Clinical Study of Chidamide in Combination With Venetoclax and Azacitidine (VAC) for Patients With Acute Myeloid Leukemia Who Did Not Achieve CR/CRi/MLFS (PR or NR) With One Cycle of Venetoclax and Azacitidine (VA).

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

Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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;

• Age 18 to 59 years;

• Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;

• Expected survival time ≥3 months;

• 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;

• Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment;

• Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable;

• Ability to understand and willingness to sign the informed consent for this trial;

• The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Sheng-Li Xue, M.D.
slxue@suda.edu.cn
+8651267781139
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 32
Treatments
Experimental: VAC regimen
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Soochow University
Collaborators: Northern Jiangsu People's Hospital, Affiliated Hospital of Nantong University, The First Affiliated Hospital of Bengbu Medical University, Jining Medical University, The Second People's Hospital of Huai'an

This content was sourced from clinicaltrials.gov