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VAH Versus VA for Salvage Therapy of R/R-AML

9. juli 2022 oppdatert av: Qifa Liu, Nanfang Hospital of Southern Medical University

Venetoclax Combined With Azacitidine Plus Homoharringtonine Versus Venetoclax Combined With Azacitidine for Relapsed/Refractory Acute Myeloid Leukemia：an Open-label, Multicentre, Randomised Phase 3 Trial

This is a prospective, multi-center, phase 3 randomized controlled clinical study comparing VAH and VA regimens for the salvage treatment of the patients with relapsed/refractory AML. Approximately 164 subjects will be randomized in a 1:1 ratio to receive VAH regimen (82 subjects) or VA regimen (82 subjects) for salvage therapy. Randomization is done with permuted blocks (block size four), and implemented through an interactive web-based response system.

VAH regimen: VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7.

VA regimen: The use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does.

The primary endpoint was overall response rate (ORR) after 2 cycles of trial therapy.

The secondary endpoints were CRc after 2 cycles of trial therapy, overall survival (OS), event-free survival (EFS) and relapse at 2 year, and safety.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

162

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Department of Hematology,Nanfang Hospital, Southern Medical University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients with relapsed/refractory AML The diagnosis of AML or relapsed AML was based on the criteria from NCCN, defined as recurrence of blasts in the peripheral blood (PB) or bone marrow (BM) blasts > 5% or development of extramedullary disease of patients after achieving a CR. Refractory AML was defined as no composite complete remission (CRc) and a reduction in bone marrow blasts of less than 50% after one cycle or no CRc after two cycles.
  2. Age 18 to 65 years old with Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  3. Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion Criteria:

  1. Acute promyelocytic leukemia (AML subtype M3)
  2. Previous exposure to the treatment of VEN-based regimen
  3. Life expectancy less than 30 days after salvage therapy
  4. Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
  5. Respiratory failure ( PaO2 ≤60mmHg)
  6. Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal [ULN], alanine aminotransferase or aspartate aminotransferase ≥2 times the ULN)
  7. Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate < 30 mL/min)
  8. ECOG performance status 3, 4 or 5
  9. With any conditions not suitable for the trial (investigators' decision)
  10. Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD was defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids.
  11. Patients with pregnancy

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: VAH regimen
VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7.
Legemiddel: VEN combined with azacitidine plus homoharringtonine
VEN begins at 100 mg on day 1 and increases stepwise over 3 days to reach the target dose of 400 mg (100 mg, 200 mg, 400 mg); dosing is continued at 400 mg per day from day 4 through day 14; azacitidine (75 mg/m²) is administered subcutaneously on days 1-7, and HHT (1 mg/m²) on days 1-7.
Aktiv komparator: VA regimen
The use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does.
Legemiddel: VEN combined with azacitidine
The use of VEN is just the same as it dose in VAH regimen except lasting for 28 days. The use of azacitidine is exactly the same as VAH group does.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall response rate
Tidsramme: At the end of Cycle 2 (each cycle is 28 days)
Overall response including CR/CRi and PR
At the end of Cycle 2 (each cycle is 28 days)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite complete remission rate
Tidsramme: At the end of Cycle 2 (each cycle is 28 days)
Composite complete remission including CR/CRi
At the end of Cycle 2 (each cycle is 28 days)
Overall survival
Tidsramme: From date of randomization until date of death from any cause, assessed up to 12 months.
The time from enrolling to death or the last follow up
From date of randomization until date of death from any cause, assessed up to 12 months.
Event-free survival
Tidsramme: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
The time from enrolling to no response, relapse, death or the last follow up
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Relapse
Tidsramme: 1 year
The event of relapse
1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Tidsramme: Baseline to 30 day post the salvage therapy
Haematological toxicity and non-haematological toxicity
Baseline to 30 day post the salvage therapy

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nanfang Hospital of Southern Medical University

Samarbeidspartnere

The Affiliated Hospital of Qingdao University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First People's Hospital of Chenzhou
Shenzhen Second People's Hospital
Peking University Shenzhen Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
Southern Medical University, China
Zhongshan People's Hospital, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
Shenzhen Hospital of Southern Medical University

Etterforskere

  • Hovedetterforsker: Qifa Liu, Department of Hematology,Nanfang Hospital, Southern Medical University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2022

Primær fullføring (Forventet)

31. desember 2022

Studiet fullført (Forventet)

31. desember 2023

Datoer for studieregistrering

Først innsendt

8. mars 2022

Først innsendt som oppfylte QC-kriteriene

9. juli 2022

Først lagt ut (Faktiske)

14. juli 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2022

Sist bekreftet

1. juli 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • VAH vs VA-2022

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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