- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05282719
Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults
A Multi-center, Phase II, Single-arm Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Jiangsu
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Suzhou, Jiangsu, Kina, 215000
- The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Male or female, Age (years) >= 18;
Patients newly diagnosed or previously treated with MDS/MPNs (CMML, MDS/MPN-U, aCML) according to 2016 WHO diagnostic criteria:
Initial diagnosis: CMML: CPSS-mol intermediate risk 2 and above; aCML; MDS/MPN-U.
Previous treatment: HMA treatment failed.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
- Liver function: Total bilirubin ≤3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3 ULN; alanine aminotransferase (ALT)≤3 ULN;
- Renal function#Ccr ≥30 ml/min;
- Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
Exclusion Criteria:
- Acute myeloid leukemia
- Myelodysplastic syndrome
- Subjects who had previously been treated with Venetoclax
- Subjects who are known to be allergic to ingredients of the study drug or their analogues
- HIV infection
- HBV-DNA or HCV-RNA positive
- Subjects with grade 2 or above cardiac failure and those considered unsuitable for inclusion by the investigator
- Subjects who are pregnant or breastfeeding
- Subjects reject to participate in the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment regime
On day 1 of each cycle, decitabine 75 mg/m2 will be given subcutaneously, and will continue for 5 days.
Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 14 day cycle is finished.
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On day 1 of each cycle, decitabine 75 mg/m2 will be given subcutaneously, and will continue for 5 days.
Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 14 day cycle is finished.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall Response Rate (ORR)
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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ORR (equals the rates of complete remission [CR]+partial remission [PR]+complete cytogenetic remission [CCyR]+marrow response [MR[+clinical benefit [CB] )of venetoclax in combination with azacitidine.
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Complete remission rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Complete remission rate of bone marrow morphology
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices as presented above.
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Hematology improvement (HI) rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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Percentages of participants with HI (erythroid/platelet/neutrophil responses)
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Complete cytogenetic remission rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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Resolution of previously present chromosomal abnormality (known to be associated with myelodysplastic, syndrome myeloproliferative neoplasms, or MDS/MPN), as seen on classic karyotyping with minimal of 20 metaphases or FISH.
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Incidence of severe infection (≥grade 3 )
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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Assessed using CTCAE 5
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Spleen response rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable.
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Symptom response rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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Improvement in symptoms as noted by decrease of ≥50% as per the MPN-SAF TSS scoring<20 were not considered eligible for measuring clinical benefit.
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Study start date to study end date, or death, whichever comes first, up to 4 years
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Suning Chen, Professor, The First Affiliated Hospital Of Soochow University
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MDS/MPN-01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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First Affiliated Hospital of Zhejiang UniversityXiangya Hospital of Central South University; Second Affiliated Hospital... og andre samarbejdspartnereRekrutteringAzacitidin i kombination med Venetoclax-behandling til MRD-positive post-allo-HSCT AML/MDS-patienterHæmatologisk malignitet | StamcelletransplantationskomplikationerKina
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Groupe Francophone des MyelodysplasiesAbbVieRekruttering
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The First Affiliated Hospital of Xiamen UniversityFujian Cancer Hospital; Dongguan People's Hospital; Huizhou Municipal Central... og andre samarbejdspartnereRekrutteringLeukæmi, Myeloid, Akut | Refraktær leukæmi | Tilbagefaldende voksen AMLKina