To hear about similar clinical trials, please enter your email below
Trial Title:
Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL
NCT ID:
NCT06393985
Condition:
B-cell Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Venetoclax
Decitabine
Blinatumomab
Conditions: Keywords:
Ph-negative B-ALL
HSCT
maintenance therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Decitabine, venetoclax and blinatumomab
Description:
Cycle1 and cycle3： Decitabine monotherapy,20 mg/m2 qd, d1-5,intravenous infusion;
Cycle2 and cycle4:
Venetoclax 200mg qd, d1-14, orally; Blinatumomab d4-17(Weight ≥45 kg, 9ug d4-6, 28ug
d7-17; Weight <45 kg, 5ug/m2 d4-6, 15ug/m2 d7-17;continuous intravenous infusion)
Arm group label:
Decitabine,venetoclax and blinatumomab
Summary:
This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and
blinatumomab could improve the 2-year progression free survival (PFS) of patients with
philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently
received an allogeneic stem cell transplant and in measurable residual disease-negative
remission.
Detailed description:
This is a phase Ⅱ, open-label, single-arm, multi-center study in patients with
philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently
received an allogeneic stem cell transplant and in minimal residual disease-negative
remission. In this study, patients will be treated with 4 cycles of maintence therapies
for up to one year (or until intolerable toxicity, death, withdrawal, or study
termination). In cycle one and three, patients will receive decitabine monotherapy, and
in cycle two and four, patients will receive a combination of venetoclax and
blinatumomab. This study aims to evaluate whether maintenance therapy with decitabine,
venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of
those patients, and explore the efficiency and safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 1.Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who underwent
an alloHSCT as follows:
1. patients in CR1 with high-risk features,including adverse clinical features,
cytogenetic or molecular alterations according to NCCN 2023.V3.
2. patients lack of achievement of complete remission after standard induction
chemotherapy.
3. patients with detectable minimal residual disease pre-transplantation.
4. patients in second and higher CR pre-transplantation. 2.Negative minimal
residual disease prior to enrollment (FCM-MRD <0.01% and fusion gene negative).
3.≥3 months post-transplantation. 4.hematopoietic reconstitution, i.e., ANC ≥0.5 x
109/L, and platelets >20 x 109/L.
5.Eastern Cooperative Oncology Group (ECOG) score: 0-2. 6.Total serum bilirubin ≤ 3
x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 5 x ULN, aspartate
aminotransferase (AST) ≤ 5 x ULN.
7.Creatinine clearance ≥ 30 mL/min. 8.Provide informed consent.
Exclusion Criteria:
- 1.Patients with another malignant disease. 2.Patients with uncontrolled active
infection. 3.Patients with left ventricular ejection fraction < 0.5 by
echocardiography or grade III/IV cardiovascular dysfunction according to the New
York Heart Association Classification.
4.Detectable minimal residual disease post-transplantation 5.Active GVHD requiring
systemic steroid therapy. 6.Patients with uncontrolled active bleeding. 7.Pregnant
and lactating women; patients of childbearing potential should be willing to
practice methods of contraception throughout the study period.
8.Patients with other commodities that the investigators considered not suitable for
the enrollment.
Gender:
All
Minimum age:
18 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
Contact:
Last name:
Xiaowen Tang, Ph.D
Phone:
67781525
Email:
xwtang1020@163.com
Investigator:
Last name:
Xiaowen Tang, Ph.D
Email:
Principal Investigator
Start date:
April 25, 2024
Completion date:
April 25, 2027
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/NCT06393985
