Sonrotoclax in Combination With Azacitidine for Previously Untreated Higher-risk Myelodysplastic Syndromes
A Prospective, Single-Center, Phase Ⅱ Clinical Study on the Efficacy and Safety of Sonrotoclax Combined With Azacitidine in Previously Untreated Patients With Higher-risk Myelodysplastic Neoplasms
To evaluate the efficacy and safety profile of sotoclax combined with azacitidine in newly diagnosed higher-risk MDS patients, including ORR, CR rate, PFS, OS and treatment-related adverse events
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
- Fase 3
Contacten en locaties
Studiecontact
- Naam: Zhurhohan Yu
- Telefoonnummer: +8617280290731
- E-mail: 1148629702@qq.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
-
Aged ≥ 18 years.
-
Diagnosed with myelodysplastic syndromes (MDS) based on bone marrow morphology, immunophenotyping, cytogenetics, and molecular testing, consistent with the WHO 2016 or 2022 classification criteria.
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High-risk MDS defined by any of the following risk stratification systems:
- nbsp; a) IPSS-R score > 3.5; or
- nbsp; b) IPSS score > 1; or
- nbsp; c) IPSS-M score > 0.
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No prior anti-tumor treatment for MDS, including hypomethylating agents or chemotherapy.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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Expected survival time ≥ 12 weeks.
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Adequate major organ function as defined below:
- nbsp; a) Creatinine clearance ≥ 50 mL/min;
- nbsp; b) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN;Left ventricular ejection fraction (LVEF) ≥ 45%.
-
Written informed consent must be obtained from the patient, legal representative, or guardian prior to any study-related procedures. The study protocol has been approved by the institutional ethics committee.
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL).
- Prior treatment with any BCL-2 inhibitor.
- History of other malignant tumors within the past 3 years (excluding cured malignancies).
- Presence of active and uncontrolled infectious diseases.
- Central nervous system (CNS) involvement.
- Severe and uncontrolled cardiac disease.
- Dry tap on bone marrow aspiration or grade 2-3 myelofibrosis.
- Pregnancy or breastfeeding status.
- Any other condition deemed inappropriate for study enrollment by the investigator.
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 |
|---|---|
|
Ander: Sonrotoclax plus Azacitidine in Newly-Diagnosed Higher-Risk Myelodysplastic Syndromes (MDS)
Patients with newly-diagnosed higher-risk MDS receive 28-day cycles of sonrotoclax (BGB-11417) plus azacitidine. Azacitidine 75 mg/m² is given subcutaneously or intravenously on Days 1-7. Sonrotoclax (RP2D 160 mg daily, Days 1-14 per cycle) undergoes 4-day dose ramp-up (20-40-80-160 mg) in Cycle 1, followed by full target dose in later cycles. |
Patients with newly-diagnosed higher-risk MDS receive 28-day cycles of sonrotoclax (BGB-11417) plus azacitidine. Azacitidine 75 mg/m² is given subcutaneously or intravenously on Days 1-7. Sonrotoclax (RP2D 160 mg daily, Days 1-14 per cycle) undergoes 4-day dose ramp-up (20-40-80-160 mg) in Cycle 1, followed by full target dose in later cycles. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Response Rate (ORR)
Tijdsspanne: Up to 24 months
|
Description: The proportion of participants achieving objective response (CR or PR) per response criteria. Unit of Measure: Proportion |
Up to 24 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Complete Remission (CR) rate
Tijdsspanne: Up to 24 months
|
Description: The proportion of participants achieving complete remission per response criteria. Unit of Measure: Proportion |
Up to 24 months
|
|
Duration of Response (DOR)
Tijdsspanne: Up to 36 months
|
Description: Time from the first documented objective response to disease progression or death from any cause. Unit of Measure: Time (months) |
Up to 36 months
|
|
Progression-Free Survival (PFS)
Tijdsspanne: Up to 36 months
|
Outcome Measure: Progression-Free Survival (PFS) Description: Time from randomization to disease progression or death from any cause. Unit of Measure: Time (months) |
Up to 36 months
|
|
Overall Survival (OS)
Tijdsspanne: Up to 36 months
|
Outcome Measure: Overall Survival (OS) Description: Time from randomization to death from any cause. Unit of Measure: Time (months) |
Up to 36 months
|
|
Hematological/non-hematological adverse events
Tijdsspanne: From first study treatment dose to 30 days after last dose
|
Description: Incidence of hematological and non-hematological adverse events, graded per CTCAE. Unit of Measure: Incidence (proportion) |
From first study treatment dose to 30 days after last dose
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
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
- 2026-MDS-1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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