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Trial Title:
Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL
NCT ID:
NCT06578546
Condition:
Ph-Positive Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Azacitidine
Venetoclax
Conditions: Keywords:
Ph-positive ALL
Venetoclax+Azacitidine+Orebatinib
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:
100mg d1, 200mg d2, 400mg d2-21, oral (Adjusted according to the plasma concentration of
venetoclax on day 4)，every 28 days for a treatment cycle.
Arm group label:
Venetoclax, Azacitidine, and Orebatinib Regimen
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle.
Arm group label:
Venetoclax, Azacitidine, and Orebatinib Regimen
Intervention type:
Drug
Intervention name:
Orebatinib
Description:
20mg qod, d4-d21, oral, every 28 days for a treatment cycle.
Arm group label:
Venetoclax, Azacitidine, and Orebatinib Regimen
Summary:
The purpose of this study is to evaluate the efficacy and safety of Venetoclax,
Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute
Lymphoblastic Leukemia.
Detailed description:
This is a phase Ⅱ, single-arm, open Label, multicenter clinical study in newly diagnosed
Ph-positive acute lymphoblastic leukemia patients. The patients will receive venetoclax,
azacitidine and orebatinib regimen in the induction treatment. The patients who respond
to induction treatment will undergo consolidation treatment, and an optional allogeneic
hematopoietic stem cell transplantation and post-transplantation maintenance treatment
with induction therapy according to patient's wishes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly diagnosed Ph-positive ALL without the history of chemotherapy or target
therapy.
2. Age ≥18.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-3.
4. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase
(ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
5. Creatinine clearance ≥ 30 mL/min.
6. Serum lipase ≤ 1.5 x ULN, amylase =< 1.5 x ULN.
7. 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. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or
hepatitis C infection.
5. Patients with uncontrolled active bleeding.
6. Patients who has participated or participating in other clinical trials related to
this disease.
7. Patients with history of previous chemotherapy or target therapy (except for oral
hydroxyurea and/or leukopheresis for lowering white blood cell counts).
8. Pregnant and lactating women; patients of childbearing potential should be willing
to practice methods of contraception throughout the study period.
9. Patients with other commodities that the investigators considered not suitable for
the enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
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, Ph.D
Phone:
67781525
Email:
xwtang1020@163.com
Start date:
February 1, 2024
Completion date:
February 1, 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/NCT06578546
