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Trial Title:
Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Myeloid Leukemia and Myelodysplastic Syndromes Undergoing Allo-HSCT
NCT ID:
NCT05823714
Condition:
Allogeneic Hematopoietic Stem Cell Transplantation
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Syndrome
Conditions: Keywords:
venetoclax
azacytidine
hematopoietic stem cell transplantation
acute myeloid leukemia
myelodysplastic syndrome
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:
VEN+AZA+Modified BUCY
Description:
Venetoclax: 200mg/day*7days（It should be combined with triazole antifungal drugs).
Azacytidine: 75mg/ m²/day*7days.
Arm group label:
VEN+AZA+Modified BUCY
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 myelodysplastic
syndrome (MDS) and high-risk or relapsed/refractory acute myeloid leukemia (AML)
undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Detailed description:
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is the only potentially
curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloid
leukemia (AML). However, relapse remains a leading cause for treatment failure after
hematopoietic cell transplantation (HCT) in patients, optimization of conditioning
regimen can improve prognosis and decrease relapse. Abnormal gene methylation is common
in AML and MDS patients. Azacytidine is a DNA methylation transferase inhibitor that can
re-express tumor suppressor genes in leukemia cells. Venetoclax is a selective BCL-2
inhibitor, which has antitumor activity against a variety of hematological malignancies.
The combination of the two drugs show a synergistic anti-tumor effect. The objective of
this study is to evaluate the safety and efficacy of VEN-AZA regimen followed by
Allo-HSCT in the treatment of high-risk MDS and high-risk or relapsed/refractory AML.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 8 to 65 years;
2. Diseases must be MDS and AML; high-risk MDS: int-2 risk, high risk by the IPSS;
IPSS-R int-risk (> 3.5 points), high risk, very high risk; high risk,very high risk
by the WPSS; high-risk or relapsed/refractory AML: (1) age≥60 years; (2) High white
blood cell count at first diagnosis (WBC≥100*10^9/L); (3) secondary AML (previous
history of MDS, myeloproliferative disease, or treatment-related AML, etc.); (4)
Complicated with extramedullary leukemia, such as central nervous system leukemia,
granulocytic sarcoma, hepatosenomegaly; （5）high risk factors and relapsed/refractory
AML（reference 2022-AML-ELN guideline）（6）not in remission or ≥CR2 before
transplantation;
3. Must need a bone marrow transplant;
4. Must have the ability to observe the efficacy and events;
5. Patient must have ability to understand and willingness to provide written informed
consent prior to participation in the study and any related procedures being
performed.
Exclusion Criteria:
1. Age <8 or >65 years;
2. Uncontrolled bacterial, viral, fungal, or other infection before conditioning
regimen;
3. Pregnant or lactating females;
4. Current participation in another clinical trial;
5. Contra-indication to one of the drug of the regimen;
6. Any other severe concurrent disease, or have a history of serious organ dysfunction
or disease involving the heart, kidney, liver or other organ system that may place
the patient at undue risk to undergo the agents included in the conditioning
regimen.
Gender:
All
Minimum age:
8 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaowen Tang, PhD
Phone:
67781525
Email:
xwtang1020@163.com
Start date:
January 20, 2022
Completion date:
January 20, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05823714
