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Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults

7. mars 2022 oppdatert av: Chen Suning, The First Affiliated Hospital of Soochow University

A Multi-center, Phase II, Single-arm Clinical Study of Venetoclax Combined With Azacytiside in the Treatment of Myelodysplastic/Myeloproliferative Neoplasms in Adults

To explore the efficacy of venetoclax combined with azacytidine in Myelodysplastic / myeloproliferative neoplasms（MDS/MPN）, so as to improve the overall survival and treatment status of MDS/MPN patients.

Studieoversikt

Status

Påmelding etter invitasjon

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

At present, there is no standardized treatment strategy for MDS/MPN. The purpose of our study is to explore the efficacy of venetoclax combined with azacytidine in the treatment of MDS/MPN, so as to improve the overall survival and treatment status of patients with MDS/MPN. After the participants were treated with four cycles of venetoclax combined with azacytidine, the efficacy was evaluated according to the 2015 adult MDS/MPN response criteria to determine the disease status. Participants with disease progression and intolerance withdrew from the study during treatment.

Studietype

Intervensjonell

Registrering (Forventet)

33

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Kina
    • Jiangsu
      • Suzhou, Jiangsu, Kina, 215000
        • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Male or female, Age (years) >= 18；

  2. 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.

  3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0,1, 2 ;
  4. Liver function: Total bilirubin ≤3 upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3 ULN; alanine aminotransferase (ALT)≤3 ULN；
  5. Renal function#Ccr ≥30 ml/min;
  6. 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:

  1. Acute myeloid leukemia
  2. Myelodysplastic syndrome
  3. Subjects who had previously been treated with Venetoclax
  4. Subjects who are known to be allergic to ingredients of the study drug or their analogues
  5. HIV infection
  6. HBV-DNA or HCV-RNA positive
  7. Subjects with grade 2 or above cardiac failure and those considered unsuitable for inclusion by the investigator
  8. Subjects who are pregnant or breastfeeding
  9. Subjects reject to participate in the study

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: venetoclax combined with azacitidine
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 navn:
  • combination of venetoclax plus azacitidine

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Response Rate (ORR)
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years

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.

  1. CR and CCyR are shown in the secondary outcome measures below.
  2. PR: Normalization of peripheral counts and hepatosplenomegaly with bone marrow blasts (and blast equivalents) reduced by 50%, but remaining>5% of cellularity except in cases of MDS/MPN with≤5% bone marrow blasts at baseline.

  3. MR: Optimal marrow response: Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices.

    Partial marrow response: Bone marrow blasts (and blast equivalents) reduced by 50%, but remaining>5% of cellularity, or reduction in grading of reticulin fibrosis from baseline on at least 2 bone marrow evaluations spaced at least 2 months apart.

  4. CB: Hematology improvement, spleen response and symptom response.
Study start date to study end date, or death, whichever comes first, up to 4 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete remission rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
  1. Bone marrow: ≤5% myeloblasts (including monocytic blast equivalent in case of CMML) with normal maturation of all cell lines and return to normal cellularity Osteomyelofibrosis absent or equal to "mild reticulin fibrosis" (≤grade 1 fibrosis).
  2. Peripheral blood: Leukocyte≤10×10E9 cells/L; Hemoglobin≥11g/dL; Platelets≥100×10E9/L, ≤450×10E9/L; Neutrophils≥1.0×10E9/L; Blasts 0%; Neutrophil precursors reduced to≤2%; Monocytes ≤1.0× 10E9/L.
  3. Extramedullary disease: Complete resolution of extramedullary disease present before therapy (eg, cutaneous disease, disease-related serous effusions), including palpable hepatosplenomegaly.
Study start date to study end date, or death, whichever comes first, up to 4 years
Complete remission rate of bone marrow morphology
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
Presence of all marrow criteria necessary for CR without normalization of peripheral blood indices as presented above.
Study start date to study end date, or death, whichever comes first, up to 4 years
Hematology improvement (HI) rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years

Percentages of participants with HI (erythroid/platelet/neutrophil responses)

  1. Erythroid response: Hemoglobin increase by≥2.0 g/dL; Transfusion independence (TI) for ≥8 week for patients requiring at least 4 packed red blood cell transfusions in the previous 8 week; Only red blood cell transfusions given based on physician's judgment for a pretreatment Hgb of ≤8.5 g/dL will count in the red blood cell TI response evaluation.
  2. Platelet response: TI when previously requiring platelet transfusions of at least a rate of 4 platelet transfusions in the previous 8 week; Pretreatment≤20×10E9/L: increase from<20×10E9/L to>20×10E9/L and by at least 100%; Pretreatment>20×10E9/L but≤100×10E9/L: absolute increase of ≥30×10E9/L.
  3. Neutrophil response: Pretreatment≤0.5×10E9/L at least 100% increase and an absolute increase≥0.5×10E9/L; Pretreatment>0.5×10E9/L and≤1.0×10E9/L, at least 50% increase and an absolute increase ≥0.5×10E9/L.
Study start date to study end date, or death, whichever comes first, up to 4 years
Complete cytogenetic remission rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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.
Study start date to study end date, or death, whichever comes first, up to 4 years
Incidence of severe infection (≥grade 3 )
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
Assessed using CTCAE 5
Study start date to study end date, or death, whichever comes first, up to 4 years
Spleen response rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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.
Study start date to study end date, or death, whichever comes first, up to 4 years
Symptom response rate
Tidsramme: Study start date to study end date, or death, whichever comes first, up to 4 years
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.
Study start date to study end date, or death, whichever comes first, up to 4 years

Samarbeidspartnere og etterforskere

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

Sponsor

The First Affiliated Hospital of Soochow University

Etterforskere

  • Hovedetterforsker: Suning Chen, Professor, The First Affiliated Hospital of Soochow 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 (Forventet)

1. april 2022

Primær fullføring (Forventet)

1. august 2022

Studiet fullført (Forventet)

1. februar 2023

Datoer for studieregistrering

Først innsendt

21. februar 2022

Først innsendt som oppfylte QC-kriteriene

7. mars 2022

Først lagt ut (Faktiske)

16. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MDS/MPN-01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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