Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML

Acute Myeloid Leukemia Clinical Trial

Official title:

Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451861
• Other study ID #: ABC-14_101
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 31, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: Guangdong Provincial People's Hospital
• Contact: Jianyu Weng
• Phone: 020-83827812
• Email: wengjianyu[@]gdph.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

Description:

Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients <60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);

2. Age =18 years old;

3. ECOG=4;

4. The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.

Exclusion Criteria:

1. Known history of allergy to the investigational drug;

2. Resistance to azacytidine, azacitidine, Venetoclax;

3. Inability to take oral medication;

4. Combined with uncontrolled active infections (including bacterial, fungal or viral infections);

5. Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;

6. Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Chidamide
Induction Therapy
• Venetoclax
Induction Therapy
• azacitidine
Induction Therapy
• Anthracyclines or anthraquinones
Induction Therapy
• cytarabine
Induction Therapy

Locations

Country	Name	City	State
China	Dongguan General Hosptial	Dongguan	Guangdong
China	Foshan First People's Hospital	Foshan	Guangdong
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The Fifth Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Hainan General Hosptial	Haikou	Hainan
China	Shenzhen second people's Hospital	Shenzhen	Guangdong
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Zhuhai General Hosptial	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite complete remission (CRc)	composite complete remission,CRc: CR + CRi + MLFS	2 months
Secondary	the rate of MRD turn negative	minimal residual disease turn negative	6 months
Secondary	DoR	Duration of remission	2 year
Secondary	RFS	Relapsed-free survival	1 year
Secondary	OS	Overall survival	1 year
Secondary	AE	Incidence of of grade 3-4 adverse events/Duration of severe myelosuppression/ Incidence of severe infection/Treatment-related mortality, according to Common Terminology Criteria for Adverse Events, versions 5.0	Throughout the study until the end, up to 2 years

External Links

•   Blood 2023; 142 (Supplement 1): 1522. doi: https://doi.org/10.1182/blood-2023-188196