Clinical trial · Interventional
Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
A Phase Ⅱ, Open Label, Single Arm, Single-Center Study to Evaluate the Efficacy and Safety of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients
NCT05433532CI-TRIAL-00076469completedPhase 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 azacitidine，venetoclax，and flumatinib in newly diagnosed Philadelphia chromosome-positive acute leukemia and accelerated phase or blast phase chronic myeloid leukemia patients.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Mixed Phenotype Acute Leukemia | Mixed Phenotype Acute Leukemia | ONTOLOGY_EXACT | 0.98 |
| Philadelphia Chromosome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Flumatinib | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Azacitidine，Venetoclax，and Flumatinib Regimen
- description
- See Detailed Description.
- interventionNames
- Drug: Azacitidine
- Drug: Venetoclax
- Drug: Flumatinib
Primary outcomes (1)
- measure
- CMR
- timeFrame
- End of cycle 2 (each cycle is 28 days)
- description
- Complete molecular remission (CMR) was defined as undetectable BCR/ABL transcript.
Secondary outcomes (4)
- measure
- CR/CRi, MRD-negative CR, CCyR, MMR
- timeFrame
- End of cycle 1 and 2 (each cycle is 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP without the history of chemotherapy or target therapy. 2. Age 18-65. 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. No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax. 8. Provide informed consent. Exclusion Criteria: 1. Patients with another malignant disease. 2. Patients has participated in or participating in other clinical trials. 3. Patients with uncontrolled active infection. 4. Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. 5. Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection. 6. Patients with uncontrolled active bleeding. 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.