Actively Recruiting
A Phase 2 Study Evaluating Safety and Efficacy of Maintenance Therapy With Hypomethylating Agent and Venetoclax After Allogeneic Stem Cell Transplantation in Patients With High-risk Myeloid Malignancies
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-08-09
78
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of maintenance therapy using hypomethylating agents combined with Venetoclax to improve leukemia-free survival in patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after allogeneic hematopoietic stem cell transplantation. This phase 2, single-arm study focuses on patients aged 18 to 70 years with specific high-risk factors for their conditions. Participants will receive hypomethylating agents, either azacitidine (32 mg/m2 daily subcutaneously) or decitabine (5 mg/m2 daily intravenously) for 5 days, plus Venetoclax (400 mg orally daily for 7 days). This maintenance treatment starts between 60 and 120 days after transplantation and is repeated every 28 days for up to 10 cycles within the first year post-transplant. Dosage adjustments for Venetoclax are made if patients are taking certain CYP450 inhibitors. During the study, participants will be monitored for leukemia-free survival, cumulative incidence of relapse, overall survival, and treatment-related toxicity up to one year after transplantation. Assessments include regular blood counts and evaluations of disease status to track response and safety throughout the maintenance period and follow-up.
CONDITIONS
Brief Title
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 70 years
- Diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
- Have received allogeneic hematopoietic cell transplantation
- AML patients must have high-risk factors such as adverse cytogenetics, need for more than 2 induction chemotherapy courses, extramedullary disease, CR2 or beyond, or measurable residual disease at transplantation
- MDS patients must have high-risk factors such as high or very high IPSS-R scores, TP53 mutation, or measurable residual disease at transplantation
- Blood counts: ANC ≥ 1.0 × 10e9/L, hemoglobin ≥ 80 g/L, platelets ≥ 50 × 10e9/L
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
You will not qualify if you...
- Concurrent use of targeted drugs
- Resistance to Venetoclax before transplantation
- Allergy to decitabine, azacitidine, or venetoclax
- Active grade II or higher acute graft-versus-host disease (GVHD)
- Active moderate or severe chronic GVHD
- Disease recurrence or graft rejection (abnormal myeloid cells >0.01%, donor cells <90%, or extramedullary malignancy)
- Blood counts: ANC < 1.0 × 10e9/L or platelets < 50 × 10e9/L
- Severe organ dysfunction (elevated liver enzymes or bilirubin, reduced kidney function)
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Pregnant or lactating women
- Other severe complications judged unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From Day 60 to up to 1 year post-transplant, repeated every 28 days
Participants receive maintenance therapy with hypomethylating agents (azacitidine or decitabine) for 5 days and venetoclax for 7 days, starting from 60 days after allogeneic stem cell transplantation. This cycle repeats every 28 days for up to 1 year post-transplant.
Up to 10 treatment cycles, each with 1 visit for drug administration
Trial Site Locations
Total: 1 location
1
Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
X
Xueying Ding, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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