To hear about similar clinical trials, please enter your email below
Trial Title:
Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia
NCT ID:
NCT06082934
Condition:
Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Dexamethasone
Venetoclax
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olverembatinib plus venetoclax and dexamethasone
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
Arm group label:
OVD regimen of Olverembatinib plus venetoclax and dexamethasone
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Hematology, Xijing Hospital, Fourth Military Medical University
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Recruiting
Contact:
Last name:
Guangxun Gao, Doctor
Phone:
02984775199
Email:
gaoguangxun@fmmu.edu.cn
Start date:
November 1, 2023
Completion date:
November 1, 2026
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082934
