Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of A Venetoclax-based, Anthracycline-free Regimen in Newly Diagnosed CBFβ::MYH11(+) AML

NCT06429098

Acute Myeloid Leukemia

RECRUITING PHASE2

VA vs DA for Newly Diagnosed Hig-risk AML

NCT05939180

Acute Myeloid Leukemia

RECRUITING PHASE2/PHASE3

Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients

NCT05433532

Philadelphia Chromosome Acute Myeloid Leukemia Acute Lymphoblastic Leukemia +2 more

COMPLETED PHASE2

Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia

NCT06082934

Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

RECRUITING PHASE1/PHASE2

Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML

NCT06827899

Acute Myeloid Leukemia

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ph-Positive Acute Lymphoblastic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Venetoclax, Azacitidine, and Orebatinib Regimen

See Detailed Description.

Group Type EXPERIMENTAL

Venetoclax

Intervention Type DRUG

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.

Azacitidine

Intervention Type DRUG

75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle.

Orebatinib

Intervention Type DRUG

20mg qod, d4-d21, oral, every 28 days for a treatment cycle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Venetoclax

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.

Intervention Type DRUG

Azacitidine

75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle.

Intervention Type DRUG

Orebatinib

20mg qod, d4-d21, oral, every 28 days for a treatment cycle.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No