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Trial Title:
Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Lymphoblastic Leukemia Undergoing Allo-HSCT
NCT ID:
NCT05809167
Condition:
Allogeneic Hematopoietic Stem Cell Transplantation
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
venetoclax
azacytidine
hematopoietic stem cell transplantation
acute lymphoblastic leukemia
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 or
relapsed/refractory acute lymphoblastic leukemia (ALL) 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 acute lymphoblastic leukemia. 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 ALL 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. Multiple case reports the efficacy of Venetoclax-based
regimens in patients with ALL is encouraging. The objective of this study is to evaluate
the feasibility, safety and efficacy of VEN-AZA bridging allogeneic hematopoietic stem
cell transplantation in the treatment of high-risk ALL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 14 to 65 years;
2. Diagnosis of high-risk or relapsed/refractory acute lymphoblastic leukemia at the
time of transplant.
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 <14 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/NCT05809167
