Ph-Positive Acute Lymphoblastic LeukemiaPhase 2NCT06578546
Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL
A Phase 2 study testing Venetoclax, Azacitidine and Orebatinib in people with Ph-Positive Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ph-Positive Acute Lymphoblastic Leukemia
- What is being tested?
- Venetoclax, Azacitidine and Orebatinib
- 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 Feb 2024to 1 Feb 2026
- Phase
- Phase 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
- Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
- Age ≥18.
- Eastern Cooperative Oncology Group (ECOG) score: 0-3.
- Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
- Creatinine clearance ≥ 30 mL/min.
- Serum lipase ≤ 1.5 x ULN, amylase =< 1.5 x ULN.
- Provide informed consent.
Who cannot join
- Patients with another malignant disease.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
- Patients with uncontrolled active bleeding.
- Patients who has participated or participating in other clinical trials related to this disease.
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- Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
- Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.
- Patients with other commodities that the investigators considered not suitable for the enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaowen Tang, Ph.D, 67781525, xwtang1020@163.com
About this study
Official title: A Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of VAO Regimen in Patients With Newly Diagnosed Ph-positive Acute Lymphoblastic Leukemia
The purpose of this study is to evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia.
Read the detailed description
This is a phase Ⅱ, single-arm, open Label, multicenter clinical study in newly diagnosed Ph-positive acute lymphoblastic leukemia patients. The patients will receive venetoclax, azacitidine and orebatinib regimen in the induction treatment. The patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.
- Conditions
- Ph-Positive Acute Lymphoblastic Leukemia
- Being tested
- Venetoclax, Azacitidine, Orebatinib
- Keywords
- Ph-positive ALL, Venetoclax+Azacitidine+Orebatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
100mg d1, 200mg d2, 400mg d2-21, oral (Adjusted according to the plasma concentration of venetoclax on day 4)，every 28 days for a treatment cycle.
AzacitidineDrug
75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle.
OrebatinibDrug
20mg qod, d4-d21, oral, every 28 days for a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax, Azacitidine, and Orebatinib Regimen | Experimental | See Detailed Description. Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: Orebatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete molecular remission（CMR）
Proportion of patients achieving CMR at the end of 1 or 2 cycles
Measured: End of cycle 1 and 2 (each cycle is 28 days)
Secondary outcomes (8)
CR
Complete remission (CR) was defined as < 5% bone marrow blasts in an aspirate with spicules and independent of transfusions.
Measured: End of cycle 1 and 2 (each cycle is 28 days)
CRi
CR with incomplete hematologic recovery (CRi) was defined as <5% bone marrow blasts, either ANC<1×10^9/L or platelets < 100×10^9/L, transfusion independence but with persistence of cytopenia.
Measured: End of cycle 1 and 2 (each cycle is 28 days)
MRD-negative CR
Minimal residual disease (MRD)-negative CR was defined as a leukemic cell count below the sensitivity threshold of 1×10-4 (0.01%) bone marrow mononuclear cells (MNCs) by multiparameter flow cytometry.
Measured: End of cycle 1 and 2 (each cycle is 28 days)
CCyR
Complete cytogenetic response (CCyR) was defined as lack of Ph in ≥ 20 bone marrow metaphases.
Measured: End of cycle 1 and 2 (each cycle is 28 days)
MMR
Major molecular response (MMR) was defined as a BCR-ABL/ABL transcript ratio of 0.1% (international scale).
Measured: End of cycle 1 and 2 (each cycle is 28 days)
Number of adverse events
Adverse events are evaluated with CTCAE V5.0
Measured: End of cycle 1 and 2 (each cycle is 28 days)
RFS
Relapse-free survival (RFS) was the duration from the day of CR to leukemia relapse, death, or last follow-up
Measured: 1 year
OS
Overall survival (OS) was the time from enrollment to death for any reason.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ph-Positive Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, Ph.D, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578546
- Sponsor's protocol ID
- VAO
- Status last verified
- Apr 2024
- First submitted
- 27 Apr 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open Label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of VAO Regimen in Patients With Newly Diagnosed Ph-positive Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06578546
- Acronym / sponsor ID
- VAO
- Conditions
- Ph-Positive Acute Lymphoblastic Leukemia
- Keywords
- Ph-positive ALL, Venetoclax+Azacitidine+Orebatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 29 Aug 2024 (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 evaluate the efficacy and safety of Venetoclax, Azacitidine Plus Orebatinib in newly diagnosed Philadelphia chromosome-positive Acute Lymphoblastic Leukemia.
Detailed description
This is a phase Ⅱ, single-arm, open Label, multicenter clinical study in newly diagnosed Ph-positive acute lymphoblastic leukemia patients. The patients will receive venetoclax, azacitidine and orebatinib regimen in the induction treatment. The patients who respond to induction treatment will undergo consolidation treatment, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with induction therapy according to patient's wishes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax, Azacitidine, and Orebatinib Regimen | Experimental | Drug: Venetoclax, Drug: Azacitidine, Drug: OrebatinibSee Detailed Description. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy.
- Age ≥18.
- Eastern Cooperative Oncology Group (ECOG) score: 0-3.
- Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN.
- Creatinine clearance ≥ 30 mL/min.
Key exclusion criteria (9 listed)
- Patients with another malignant disease.
- Patients with uncontrolled active infection.
- Patients with left ventricular ejection fraction < 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
- Patients with uncontrolled active bleeding.
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 |
|---|---|---|
| Venetoclax100mg d1, 200mg d2, 400mg d2-21, oral (Adjusted according to the plasma concentration of venetoclax on day 4)，every 28 days for a treatment cycle. | Drug | Venetoclax, Azacitidine, and Orebatinib Regimen |
| Azacitidine75mg/m2 qd, d1-d7, subcutaneous injection, every 28 days for a treatment cycle. | Drug | Venetoclax, Azacitidine, and Orebatinib Regimen |
| Orebatinib20mg qod, d4-d21, oral, every 28 days for a treatment cycle. | Drug | Venetoclax, Azacitidine, and Orebatinib Regimen |
Primary outcome
complete molecular remission（CMR）
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
Proportion of patients achieving CMR at the end of 1 or 2 cycles
8 secondary outcomes
CR
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
CRi
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
MRD-negative CR
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
CCyR
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
MMR
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
Number of adverse events
Time frame: End of cycle 1 and 2 (each cycle is 28 days)
RFS
Time frame: 1 year
OS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Xiaowen Tang, Ph.D study chair
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax, Azacitidine and Orebatinib in people with Ph-Positive Acute Lymphoblastic Leukemia, run by The First Affiliated Hospital of Soochow University 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 7 inclusion and 9 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 29 Aug 2024. 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 phase mean?
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?
Contact Xiaowen Tang, Ph.D (67781525, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete molecular remission（CMR） (time frame: End of cycle 1 and 2 (each cycle is 28 days)). 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 29 Aug 2024.