Newly-diagnosed Ph+ Acute Lymphoblastic LeukemiaPhase 1/2NCT06082934
Olverembatinib Plus Venetoclax and Dexamethasone for Treatment-naïve Ph+ Acute Lymphoblastic Leukemia
A Phase 1/2 study testing Olverembatinib plus venetoclax and dexamethasone in people with Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
- What is being tested?
- Olverembatinib plus venetoclax and dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shannxi, 710032
Guangxun Gao, Doctor, 02984775199, gaoguangxun@fmmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- Olverembatinib plus venetoclax and dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olverembatinib plus venetoclax and dexamethasoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| OVD regimen of Olverembatinib plus venetoclax and dexamethasone | Experimental | 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 Receives: Drug: Olverembatinib plus venetoclax and dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates
Measured: Three years
Negative measurable residual disease (MRD) rates
Measured: Three years
Complete molecular remissions (CMR) rates
Measured: Three years
Progression-free survival (PFS)
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly-diagnosed Ph+ Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082934
- Sponsor's protocol ID
- 20232082
- Status last verified
- Nov 2022
- First submitted
- 9 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Single-arm Study of Olverembatinib Plus Venetoclax and Dexamethasone in Patients of Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06082934
- Acronym / sponsor ID
- 20232082
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OVD regimen of Olverembatinib plus venetoclax and dexamethasone | Experimental | Drug: Olverembatinib plus venetoclax and dexamethasoneOlverembatinib: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of newly-diagnosed Ph+ acute lymphoblastic leukemia
- Age >= 18
- Adequate hepatic function
- Adequate renal function
- Adequate heart function
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olverembatinib plus venetoclax and dexamethasoneOlverembatinib: 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 | OVD regimen of Olverembatinib plus venetoclax and dexamethasone |
Primary outcome
Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates
Time frame: Three years
Negative measurable residual disease (MRD) rates
Time frame: Three years
Complete molecular remissions (CMR) rates
Time frame: Three years
Progression-free survival (PFS)
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Hematology, Xijing Hospital, Fourth Military Medical University
Xi'an, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Olverembatinib plus venetoclax and dexamethasone in people with Newly-diagnosed Ph+ Acute Lymphoblastic Leukemia, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rates (time frame: Three years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.