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

NCT06578546 | Recruiting Phase 2 DMC

• 1 other identifier: VAO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ph-Positive Acute Lymphoblastic Leukemia

Keywords

Ph-positive ALL; Venetoclax+Azacitidine+Orebatinib

Outcome Measures

Primary Outcomes (1)

• complete molecular remission（CMR）

  Proportion of patients achieving CMR at the end of 1 or 2 cycles

  End of cycle 1 and 2 (each cycle is 28 days)

Secondary Outcomes (8)

• CR

  End of cycle 1 and 2 (each cycle is 28 days)

• CRi

  End of cycle 1 and 2 (each cycle is 28 days)

• MRD-negative CR

  End of cycle 1 and 2 (each cycle is 28 days)

• CCyR

  End of cycle 1 and 2 (each cycle is 28 days)

• MMR

  End of cycle 1 and 2 (each cycle is 28 days)

Study Arms (1)

Venetoclax, Azacitidine, and Orebatinib Regimen

EXPERIMENTAL

See Detailed Description.

Drug: Venetoclax; Drug: Azacitidine; Drug: Orebatinib

Interventions

Venetoclax 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.

Venetoclax, Azacitidine, and Orebatinib Regimen

Azacitidine DRUG

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

Venetoclax, Azacitidine, and Orebatinib Regimen

Orebatinib DRUG

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

Venetoclax, Azacitidine, and Orebatinib Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
• Age ≥18.
• Eastern Cooperative Oncology Group (ECOG) score: 0-3.
• Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
• Creatinine clearance ≥ 30 mL/min.
• Serum lipase ≤ 1.5 x ULN, amylase =\< 1.5 x ULN.
• Provide informed consent.

You may not qualify if:

• Patients with another malignant disease.
• Patients with uncontrolled active infection.
• Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
• Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
• Patients with uncontrolled active bleeding.
• Patients who has participated or participating in other clinical trials related to this disease.
• Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
• Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
• Patients with other commodities that the investigators considered not suitable for the enrollment.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Interventions

venetoclax; Azacitidine

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Xiaowen Tang, Ph.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

Central Study Contacts

Xiaowen Tang, Ph.D

CONTACT

67781525; xwtang1020@163.com

Depei Wu, Ph.D

CONTACT

67781856; drwudepei@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: August 29, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)