- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07643636
Chidamide, Venetoclax, Azacitidine, and Homoharringtonine for High-risk Fit AML
A Single-arm, Single-center Clinical Trial Evaluating the Efficacy and Safety of a Regimen Combining Chidamide With Venetoclax, Azacitidine, and Homoharringtonine in the Treatment of Intermediate- to High-risk Fit AML Patients
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Zhangkun Li
- Telefonnummer: 0769-28637333
- E-post: lzk8239@163.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Newly diagnosed fit-AML patients classified per the World Health Organization (WHO) classification criteria.
- Age ranging from 18 to 60 years, no restriction on gender.
- No prior anti-AML systemic therapy after AML diagnosis; cytoreductive treatment (e.g., hydroxyurea or cytarabine at a daily dose <1.0 g) is permitted as exception.
- Estimated overall survival ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤3 points.
- Renal function: calculated creatinine clearance (CrCl) ≥30 mL/min.
- Hepatic function: alanine aminotransferase (ALT) <5× upper limit of normal (ULN); total bilirubin <3× ULN.
- Able to provide written informed consent and understand as well as comply with all study-specified procedures.
Exclusion Criteria:
- Patients stratified as favorable-risk AML defined by NCCN Guidelines 2022, including cytogenetic aberrations: t(8;21)(q22;q22.1); RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11.
- Confirmed acute promyelocytic leukemia (APL). AML complicated with central nervous system (CNS) leukemia infiltration.
- Cardiac function exceeding NYHA functional class II.
Confirmed human immunodeficiency virus (HIV) infection or other uncontrolled clinically significant comorbidities, including but not limited to:
- Uncontrolled or active systemic infection (viral, bacterial or fungal); ② Concurrent second primary malignancy requiring urgent clinical intervention.
6. Patients unable to receive oral chidamide and/or venetoclax administration. 7. Known hypersensitivity to any investigational product. 8. Pregnant or breastfeeding female subjects. 9. Inability to understand or adhere to the study protocol requirements. 10.Subjects deemed unsuitable for enrollment at the investigator's discretion
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Chidamide , Venetoclax, Azacitidine, Homoharringtonine
|
Induction (Chi+VAH Regimen): Cycle 1: Chi+VAH regimen (28-day cycle). Assessment & Cycle 2: CR/CRi: Repeat one cycle → Proceed to post-remission therapy. PR: Repeat one cycle → Re-assess. If CR/CRi → Proceed to post-remission therapy. NR: Discontinue study. Post-Remission / Consolidation: 1-2 cycles of either intermediate-dose Cytarabine (± targeted therapy) OR the Chi+VAH regimen. Eligible patients should proceed to allogeneic HSCT. Maintenance (Non-transplant): MRD-negative: VA (Venetoclax + Azacitidine) until relapse, intolerance, or 1 year. MRD-positive: Chi+VAH or clinical trial until MRD negativity, then switch to VA maintenance. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Composite Complete Remission Rate (CR+CRi)
Tidsram: the First Induction Cycle (28days)
|
the First Induction Cycle (28days)
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
MRD negativity rate after the first induction cycle
Tidsram: 28 days
|
28 days
|
|
Composite CR/CRi rate after the second induction cycle
Tidsram: 56 days
|
56 days
|
|
2-year overall survival (OS) rate
Tidsram: 2 years
|
2 years
|
|
2-year relapse-free survival (RFS) rate
Tidsram: 2 years
|
2 years
|
|
Bridging Rate to Allo-HSCT
Tidsram: 2 years
|
2 years
|
|
Non-relapse mortality (NRM)
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CSIIT-A58
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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