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Trial Title:
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.
NCT ID:
NCT05841771
Condition:
Hypomethylating Agent
Venetoclax
Myeloid Malignancy
Conditions: Official terms:
Neoplasms
Azacitidine
Decitabine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Participants will receive maintenance therapy with venetoclax and azacitidine or
decitabine after allogeneic stem cell transplantation.
Azacitidine will be administered once daily subcutaneously (32mg/m2/d) on days 1-5, and
venetoclax will be administered once daily orally (400mg/day) on days 1-7. If the patient
is refractory or allergic to azacitidine, they will receive decitabine. Decitabine will
be administered intravenously (5mg/m2/d) on days 1-5. If the patient is treated with
CYP450 inhibitors(such as posaconazole or voriconazole), the dose of venetoclax will
reduce to 100 mg once daily on days 1-7. Maintenance therapy will start from the 60th to
120th days after allogeneic hematopoietic stem cell transplantation and repeat every 28
days for up to 10 cycles within the first year after transplantation.
Arm group label:
AZA-VEN maintenance
Other name:
BCL-2 inhibitor
Intervention type:
Drug
Intervention name:
Azacitidine or decitabine
Description:
azacytidine 32mg/m2 or decitabine 5mg/m2
Arm group label:
AZA-VEN maintenance
Other name:
Hypomethylating Agent
Summary:
The main objective of the study is to evaluate the efficacy and safety of maintenance
therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for
high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .
Detailed description:
This is a prospective single-arm study. Patients with high-risk AML or MDS aged between
18-70 years old will enroll in the study. They will be given hypomethylating agents
(azacytidine 32mg/m2 or decitabine 5mg/m2) for 5 days and venetoclax 400mg/d for 7 days
after allogeneic hematopoietic stem cell transplantation. The maintenance therapy will
start from 60th days posttransplant, repeated every 28 days until up to 1-year
posttransplant. The 1-year leukemia-free survival rate,1-year cumulative recurrence rate,
and 1-year overall survival will be analyzed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with AML or MDS and have received allogeneic hematopoietic cell
transplantation;
- Patients with AML must have one of the following high-risk factors: Cytogenetics and
molecular features consistent with adverse risk group by European LeukemiaNet
classification for AML; require more than 2 courses of induction chemotherapy to
reach complete remission; Extramedullary myeloid malignancy;≥CR2; Presence of
measurable residual disease at the time of HSCT. *
- Patients with MDS must have one of the following high-risk factors: IPSS-R scores
are high-risk or very high-risk; Presence of TP53 mutation; Presence of measurable
residual disease at the time of HSCT. *
- CBC: ANC ≥ 1.0 × 10e9/L, Hb ≥ 80g/L, and PLT ≥ 50 × 10e9/L;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Presence of measurable residual disease at the time of HSCT is defined as the
following: Blast percentage in bone marrow detected by flow cytometry ≥0.01%;
Presence of fusion gene or mutated gene by qPCR.
Exclusion Criteria:
- Concurrent use of targeted drugs ;
- Resistant to Venetoclax before transplantation;
- Allergic to decitabine , Azacitidine or venetoclax;
- Active grade II or higher acute GVHD ;
- Active moderate or severe chronic GVHD ;
- Diseases recurrence (abnormal myeloid cells detected by flow cytometry >0.01%,
presence of WT1 or other genes, or extramedullary malignancy ), percentage of donor
cells in bone marrow <90% or graft rejection:
- CBC: ANC < 1.0 × 10e9/L, or PLT < 50 × 10e9/L;
- Severe organ dysfunction: Elevated Aspartate transaminase (AST) /alanine
transaminase (ALT), or direct bilirubin >3 times upper limit of normal; Creatinine
clearance (Ccr)<50mL/min or serum creatinine >1.5 times upper limit of normal,
whether hemodialysis treatment is performed;
- Active uncontrolled systemic fungal, bacterial, or viral infection
- Pregnant or lactating women;
- Other severe complications and not suitable judged by researchers.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Jiao Tong University School of Medicine Affilated Shanghai General Hospital
Address:
City:
Shanghai
Zip:
200080
Country:
China
Status:
Recruiting
Contact:
Last name:
Xueying Ding, Ph.D
Phone:
86-21-36126060
Email:
shiyicss@126.com
Contact backup:
Last name:
Yanhong Zhu, M.S
Phone:
86-21-63240090
Phone ext:
6213
Email:
sfph_edu2@163.com
Investigator:
Last name:
Liping Wan, M.D., Ph.D.
Email:
Principal Investigator
Start date:
January 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841771