Clinical trial · Interventional
Chemotherapy-free Regimen of Venetoclax, Azacitidine Plus Orebatinib (VAO Regimen) for Newly Diagnosed ph+ALL
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
NCT06578546CI-TRIAL-00080334unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ph-Positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Orebatinib | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax, Azacitidine, and Orebatinib Regimen
- description
- See Detailed Description.
- interventionNames
- Drug: Venetoclax
- Drug: Azacitidine
- Drug: Orebatinib
Primary outcomes (1)
- measure
- complete molecular remission（CMR）
- timeFrame
- End of cycle 1 and 2 (each cycle is 28 days)
- description
- Proportion of patients achieving CMR at the end of 1 or 2 cycles
Secondary outcomes (8)
- measure
- CR
- timeFrame
- End of cycle 1 and 2 (each cycle is 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed Ph-positive ALL without the history of chemotherapy or target therapy. 2. Age ≥18. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-3. 4. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 1.5 x ULN, aspartate aminotransferase (AST) ≤ 1.5 x ULN. 5. Creatinine clearance ≥ 30 mL/min. 6. Serum lipase ≤ 1.5 x ULN, amylase =\< 1.5 x ULN. 7. Provide informed consent. Exclusion Criteria: 1. Patients with another malignant disease. 2. Patients with uncontrolled active infection. 3. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. 4. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection. 5. Patients with uncontrolled active bleeding. 6. Patients who has participated or participating in other clinical trials related to this disease. 7. Patients with history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts). 8. Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period. 9. Patients with other commodities that the investigators considered not suitable for the enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.