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

August 27, 2024 updated by: The First Affiliated Hospital of Soochow University

A Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of VAO Regimen in Patients With Newly Diagnosed Ph-positive Acute Lymphoblastic Leukemia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Venetoclax, Azacitidine, and Orebatinib Regimen
See Detailed Description.
Drug: 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.
Drug: Azacitidine
75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle.
Drug: Orebatinib
20mg qod, d4-d21, oral, every 28 days for a treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete molecular remission（CMR）
Time Frame: End of cycle 1 and 2 (each cycle is 28 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: End of cycle 1 and 2 (each cycle is 28 days)
Adverse events are evaluated with CTCAE V5.0
End of cycle 1 and 2 (each cycle is 28 days)
CR
Time Frame: End of cycle 1 and 2 (each cycle is 28 days)
Complete remission (CR) was defined as < 5% bone marrow blasts in an aspirate with spicules and independent of transfusions.
End of cycle 1 and 2 (each cycle is 28 days)
CRi
Time Frame: End of cycle 1 and 2 (each cycle is 28 days)
CR with incomplete hematologic recovery (CRi) was defined as <5% bone marrow blasts, either ANC<1×10^9/L or platelets < 100×10^9/L, transfusion independence but with persistence of cytopenia.
End of cycle 1 and 2 (each cycle is 28 days)
MRD-negative CR
Time Frame: End of cycle 1 and 2 (each cycle is 28 days)
Minimal residual disease (MRD)-negative CR was defined as a leukemic cell count below the sensitivity threshold of 1×10-4 (0.01%) bone marrow mononuclear cells (MNCs) by multiparameter flow cytometry.
End of cycle 1 and 2 (each cycle is 28 days)
CCyR
Time Frame: End of cycle 1 and 2 (each cycle is 28 days)
Complete cytogenetic response (CCyR) was defined as lack of Ph in ≥ 20 bone marrow metaphases.
End of cycle 1 and 2 (each cycle is 28 days)
MMR
Time Frame: End of cycle 1 and 2 (each cycle is 28 days)
Major molecular response (MMR) was defined as a BCR-ABL/ABL transcript ratio of 0.1% (international scale).
End of cycle 1 and 2 (each cycle is 28 days)
RFS
Time Frame: 1 year
Relapse-free survival (RFS) was the duration from the day of CR to leukemia relapse, death, or last follow-up
1 year
OS
Time Frame: 1 year
Overall survival (OS) was the time from enrollment to death for any reason.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Study Chair: Xiaowen Tang, Ph.D, The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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