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
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zhurhohan Yu
- Numéro de téléphone: +8617280290731
- E-mail: 1148629702@qq.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
-
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.
-
No prior anti-tumor treatment for MDS, including hypomethylating agents or chemotherapy.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
-
Expected survival time ≥ 12 weeks.
-
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Response Rate (ORR)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete Remission (CR) rate
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-MDS-1
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .