Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

Single Arm,Open Label,Phase I Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659992
• Other study ID #: S2022-240
• Status: Recruiting
• Phase: Phase 1
• Start date: January 10, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: November 2022
• Source: Chinese PLA General Hospital
• Contact: Daihong Liu, Doctor
• Phone: +8613681171597
• Email: daihongrm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.

Description:

Despite the availability of hematopoietic stem cell transplantation and the emergence of many new therapeutic drugs, the prognosis of newly diagnosed acute myeloid leukemia is still poor. In order to improve the outcome of patients with de novo AML, participants developed a venetoclax combined with CACAG regimen in the treatment of de novo AML. In this study, participants intent to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed AML.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who are able to understand and willing to sign the informed consent form (ICF).
• All patients should aged 14 to75 years,no gender limitation.
• Patients who are newly diagnosed with AML.
• Liver function: ALT and AST=2.5 times the upper limit of normal ,bilirubin=2 times the upper limit of normal;
• Renal function: creatinine =the upper limit of normal;
• Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
• The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival = 4 months.
• Patients without severe allergic constitution.

Exclusion Criteria:

• Patients with allergy or contraindication to the study drug;
• Female patients who are pregnant or breast-feeding.
• Patients with active infection
• Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
• Patients with mental illness or other states unable to comply with the protocol;
• Less than 6 weeks after surgical operation of important organs.
• Liver function: ALT and AST>2.5 times the upper limit of normal ,bilirubin>2 times the upper limit of normal;Renal function: creatinine >the upper limit of normal;
• The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte
azacytidine (75 mg/m2/day, days 1 to 7). cytarabine (75 mg/m2 bid, days 1 to 5). aclamycin (10 mg/m2/day, day1,3,5). Chidamide (30 mg/day , days 0,3). venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ). granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Defined as the percentage of participants achieving a best overall response of complete response (CR), CR with incomplete blood count recovery (CRi), or partial response (PR).	2 months after study treatment
Secondary	Complete Remission (CR) Rate	Defined in accordance with the IWG Response Criteria in AML. Bone marrow blasts <5 percent; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.	2 months after study treatment
Secondary	CR with Incomplete Blood Count Recovery Rate	All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL)	2 months after study treatment
Secondary	Partial Remission (PR) Rate:	All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pre-treatment bone marrow blast percentage by at least 50 percent.	2 months after study treatment
Secondary	Rate of Minimal Residual Disease (MRD)-Negative Response:	Percentage of participants who achieved MRD-negative response, defined as < 1 leukemia cell per 10,000 leukocytes as assessed by flow cytometry or < 0.01% as assessed by PCR of a bone marrow aspirate.	after two courses of chemotherapy (each course is 28 days)
Secondary	Progression Free Survival (PFS)	PFS was defined as time from the date joining the clinical study to the date of disease progression (PD) or date of death due to any cause, whichever occurred first.	180 days after study treatment
Secondary	Overall Survival (OS)	Defined as the time from joining the clinical study to death due to any cause.	180 days after study treatment
Secondary	Rate of Participants With Adverse Events	Percentage of Participants with 3 or 4 grade Adverse Events reported through 28 days post last study medication administration.	Through 28 days post last study medication administration