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

Primary Purpose

Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Olverembatinib plus venetoclax and dexamethasone
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hematology, Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OVD regimen of Olverembatinib plus venetoclax and dexamethasone

Arm Description

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

Outcomes

Primary Outcome Measures

Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates
Negative measurable residual disease (MRD) rates
Complete molecular remissions (CMR) rates
Progression-free survival (PFS)

Secondary Outcome Measures

Full Information

First Posted
October 9, 2023
Last Updated
October 9, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06082934
Brief Title
Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia
Official Title
An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OVD regimen of Olverembatinib plus venetoclax and dexamethasone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Olverembatinib plus venetoclax and dexamethasone
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates
Time Frame
Three years
Title
Negative measurable residual disease (MRD) rates
Time Frame
Three years
Title
Complete molecular remissions (CMR) rates
Time Frame
Three years
Title
Progression-free survival (PFS)
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Hematology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangxun Gao, Doctor
Phone
02984775199
Email
gaoguangxun@fmmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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