Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Lymphoblastic Leukemia Undergoing Allo-HSCT
NCT05809167 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2023-04-12
Summary
The purpose of this prospective, open-label, single-center study is to evaluate the efficacy and safety of VEN-AZA (venetoclax and azacytidine) followed by modified BUCY (busulfan and cyclophosphamide) as conditioning regimen for high-risk or relapsed/refractory acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Acute Lymphoblastic Leukemia
Interventions
- DRUG
-
VEN+AZA+Modified BUCY
Venetoclax: 200mg/day\*7days(It should be combined with triazole antifungal drugs). Azacytidine: 75mg/ m²/day\*7days.
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
Depei Wu Wu, MD · The First Affiliated Hospital of Soochow University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-01-20
- Primary Completion
- 2025-01-20
- Completion
- 2026-01-20
Countries
- China
Study Locations
More Related Trials
-
VA as Maintenance Therapy Post Allo-HSCT in MDS and AML
NCT06598384 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Azacitidine in Combination With Venetoclax Treatment for MRD Positive Post Allo-HSCT AML/MDS Patients
NCT04809181 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
NCT04161885 ·Status: TERMINATED ·Phase: PHASE3
-
Study to Assess Adverse Events and Change in Disease State of Oral Venetoclax in Combination With Subcutaneous (SC) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Intensive Chemotherapy in China
NCT05144243 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
NCT05841771 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia
NCT02287233 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients
NCT06237192 ·Status: RECRUITING ·Phase: NA
-
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT
NCT03256071 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.
NCT04904237 ·Status: UNKNOWN ·Phase: PHASE2
-
Venetoclax and Azacitidine for the Management of Molecular Relapse/Progression in Adult NPM1-mutated Acute Myeloid Leukemia
NCT04867928 ·Status: UNKNOWN ·Phase: PHASE2
-
Study of Venetoclax in Combination With Azacytidine in AML Patients Selected Using Ex Vivo Drug Sensitivity Screening
NCT04267081 ·Status: COMPLETED ·Phase: PHASE2
-
AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission
NCT05404906 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Azacitidine Combined With Venetoclax and ATRA in Newly Diagnosed AML
NCT05654194 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia (AML)
NCT06773208 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia
NCT06903702 ·Status: RECRUITING ·Phase: PHASE2
-
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
NCT03613532 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
NCT05660473 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase 2 Study of Venetoclax in Combination With Low-dose HHT, G-CSF, and AZA as First-line Treatment for Newly Diagnosed Elderly AML Patients Unfit for Intensive Chemotherapy
NCT04824924 ·Status: UNKNOWN ·Phase: PHASE2
-
A Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction
NCT07082452 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Real World Use of Azacitidine and Venetoclax in Acute Myeloid Leukemia in Frontline and Relapse/Refractory
NCT06429670 ·Status: COMPLETED
-
Venetoclax in Patients With MDS or AML in Relapse After AHSCT
NCT05226455 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
SL-401 in Combination With Azacitidine or Azacitidine/Venetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
NCT03113643 ·Status: RECRUITING ·Phase: PHASE1
-
Addition of Gemcitabine to Pre Allo-HSCT Conditioning for Acute Lymphoblastic Leukemia
NCT03339700 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
NCT02993523 ·Status: COMPLETED ·Phase: PHASE3
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
NCT04801797 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2