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

October 9, 2023 updated by: Xijing Hospital

An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

The purpose of this study is to explore the efficacy and safety of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

To determine the Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates, the measurable residual disease (MRD) rates, the complete molecular remissions (CMR) rates and the progression-free survival (PFS) of the OVD chemotherapy-free regimen (Olverembatinib, venetoclax and dexamethasone) in patients with newly-diagnosed Ph+ALL.

SECONDARY OBJECTIVES:

To describe the toxicities of the OVD regimen. To assess the quality of life and overall survival of the OVD chemotherapy-free regimen in patients with newly-diagnosed Ph+ALL.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • Recruiting
        • Department of Hematology, Xijing Hospital, Fourth Military Medical 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:

  • Diagnosis of newly-diagnosed Ph+ acute lymphoblastic leukemia
  • Age >= 18
  • Adequate hepatic function
  • Adequate renal function
  • Adequate heart function
  • Life expectancy of more than 3 months
  • Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity from the time of signing the informed consent for through 120 days after the last dose of study medication.
  • Women of childbearing potential have negative pregnancy test within 72 hours of initiating study drug dosing.
  • Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the POMALYST REMS program.

Exclusion Criteria:

  • Current or anticipated use of other investigational agents.
  • Female patients who are lactating or have a positive serum pregnancy test during the screening period.
  • Major surgery within 3 weeks prior to first dose
  • Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
  • Known or suspected HIV infection, known HIV seropositivity
  • Active hepatitis infection
  • Has known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) <50% of predicted normal
  • Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance, including difficulty swallowing

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: OVD regimen of Olverembatinib plus venetoclax and dexamethasone
Olverembatinib: orally every other day at a dose of 40mg Venetoclax: in a daily ramp-up strategy (100 mg d4, 200 mg d5, 400 mg d6-17) Dexamethasone: intravenously 10mg, d1-14, 5mg, d15-28
Drug: Olverembatinib plus venetoclax and dexamethasone
Olverembatinib: orally every other day at a dose of 40mg Venetoclax: in a daily ramp-up strategy (100 mg d4, 200 mg d5, 400 mg d6-17) Dexamethasone: intravenously 10mg, d1-14, 5mg, d15-28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates
Time Frame: Three years
Three years
Negative measurable residual disease (MRD) rates
Time Frame: Three years
Three years
Complete molecular remissions (CMR) rates
Time Frame: Three years
Three years
Progression-free survival (PFS)
Time Frame: Three years
Three years

Collaborators and Investigators

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

Sponsor

Xijing Hospital

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 (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20232082

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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