- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Zhangkun Li
- Telefonnummer: 0769-28637333
- E-post: lzk8239@163.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Composite Complete Remission Rate (CR+CRi)
Tidsramme: the First Induction Cycle (28days)
|
the First Induction Cycle (28days)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
MRD negativity rate after the first induction cycle
Tidsramme: 28 days
|
28 days
|
|
Composite CR/CRi rate after the second induction cycle
Tidsramme: 56 days
|
56 days
|
|
2-year overall survival (OS) rate
Tidsramme: 2 years
|
2 years
|
|
2-year relapse-free survival (RFS) rate
Tidsramme: 2 years
|
2 years
|
|
Bridging Rate to Allo-HSCT
Tidsramme: 2 years
|
2 years
|
|
Non-relapse mortality (NRM)
Tidsramme: 2 years
|
2 years
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSIIT-A58
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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