NCT06451861 Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML
| NCT ID | NCT06451861 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guangdong Provincial People's Hospital |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-08-21 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2024-08-21 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Jianyu Weng
PRINCIPAL INVESTIGATOR
Guangdong Provincial People Hosptial
Frequently Asked Questions
Who can join the NCT06451861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06451861 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06451861 currently recruiting?
Yes, NCT06451861 is actively recruiting participants. Contact the research team at wengjianyu@gdph.org.cn for enrollment information.
Where is the NCT06451861 trial being conducted?
This trial is being conducted at Dongguan, China, Foshan, China, Guangzhou, China, Guangzhou, China and 9 additional locations.
Who is sponsoring the NCT06451861 clinical trial?
NCT06451861 is sponsored by Guangdong Provincial People's Hospital. The principal investigator is Jianyu Weng at Guangdong Provincial People Hosptial. The trial plans to enroll 240 participants.
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