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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Jiangsu
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Suzhou, Jiangsu, China, 215000
- The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall Response Rate (ORR)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Complete remission rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Study start date to study end date, or death, whichever comes first, up to 4 years
|
Complete cytogenetic remission rate
Tijdsspanne: 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 )
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Suning Chen, Professor, The First Affiliated Hospital Of Soochow University
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MDS/MPN-01
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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