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

Phase 2

Not yet recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Anthracyclines or anthraquinones; Drug: Chidamide; Drug: Venetoclax; Drug: cytarabine; Drug: azacitidine

• Registration Number: NCT06451861
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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

Detailed 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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-05
• Study Start: 2024-05-31
• Study First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2026-12-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABC-14 regimen	Venetoclax	AZA,Venetoclax,Chidamide
ABC-14 regimen	azacitidine	AZA,Venetoclax,Chidamide
3+7 chemotherapy regimen	cytarabine	Daunorubicin/idarubicin/mitoxantrone and cytarabine
AB-14 regimen	Venetoclax	AZA,Venetoclax
3+7 chemotherapy regimen	Anthracyclines or anthraquinones	Daunorubicin/idarubicin/mitoxantrone and cytarabine
ABC-14 regimen	Chidamide	AZA,Venetoclax,Chidamide
AB-14 regimen	azacitidine	AZA,Venetoclax

Primary Outcome Measures

Name	Time	Method
Composite complete remission (CRc)	2 months	composite complete remission，CRc: CR + CRi + MLFS

Secondary Outcome Measures

Name	Time	Method
the rate of MRD turn negative	6 months	minimal residual disease turn negative
AE	Throughout the study until the end, up to 2 years	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
RFS	1 year	Relapsed-free survival
DoR	2 year	Duration of remission
OS	1 year	Overall survival

Trial Locations

Locations (13)

Foshan First People's Hospital; 🇨🇳 Foshan, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Fifth Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Dongguan General Hosptial; 🇨🇳 Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangdong Pharmaceutical University; 🇨🇳 Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Shenzhen second people's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University; 🇨🇳 Zhanjiang, Guangdong, China

Zhuhai General Hosptial; 🇨🇳 Zhuhai, Guangdong, China

Hainan General Hosptial; 🇨🇳 Haikou, Hainan, China