NCT05433532CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 25 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 14 Jun 2022
- Start date
- 1 May 2022
- Primary completion date
- 13 Apr 2024
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute lymphoblastic leukaemia, Chronic myeloid leukaemia, Chronic lymphocytic leukaemia, Acute myeloid leukemia
- NCT number
- NCT05433532
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 1 May 2022 to the primary completion date, 13 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with another malignant disease.
- Patients with uncontrolled active infection.
- Patients with HIV infection, active tuberculosis infection, or active hepatitis B or hepatitis C infection.
- Patients with uncontrolled active bleeding.
Lab values
- 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 history of previous chemotherapy or target therapy (except for oral hydroxyurea and/or leukopheresis for lowering white blood cell counts).
Other
- Patients has participated in or participating in other clinical trials.
- 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.
Who the study is looking for
- Newly diagnosed Ph-positive ALL/AML/MPAL and CML-AP/BP without the history of chemotherapy or target therapy.
- Age 18-65.
- 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.
- No consumption of grapefruit, grapefruit products, Seville oranges, or star fruit within 3 days prior to starting venetoclax.
- Provide informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.