Status:
RECRUITING
Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia
Lead Sponsor:
Xijing Hospital
Conditions:
Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 molecul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06082934
Start Date
November 1 2023
End Date
November 1 2026
Last Update
October 13 2023
Active Locations (1)
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1
Department of Hematology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, China, 710032