NCT05805098RecruitingPhase 2/3
Venetoclax Combined With Homoharringtonine and Cytarabine in Induction for AML
Venetoclax in Combination With Homoharringtonine and Cytarabine in Newly Diagnosed Subjects With Acute Myeloid Leukemia: a Phase 2/3, the Single-arm, Open-label, Monocentric Study
Source: ClinicalTrials.gov · Last updated 7 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to evaluate the efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of newly diagnosed acute myeloid leukemia.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Mar 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05805098
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- From 1 Mar 2023 to the primary completion date, 1 Mar 2025
- 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.
Prior treatment
- Patient is ineligible for treatment with intensive chemotherapy
Other illness
- Patient with active infection not controlled, active bleeding from vital organs
- Patient with history of clinically significant drug or alcohol abuse that would adversely affect evaluation in this study
- Patient has any other significant medical or psychiatric history that in the opinion of the investigator would adversely affect participation in this study.
- Patients with uncontrolled infection with human immunodeficiency virus (HIV) or active Hepatitis B or C
Age
- \> 60 years of age or \<18 years of age
Other
- Acute promyelocytic leukemia (M3)
- Female who are pregnant, breast feeding or childbearing potential without a negative urine pregnancy test at screen.
- Patients deemed unsuitable for enrolment by the investigator.
Who the study is looking for
- Patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent.
- patients must have confirmation of AML by WHO criteria, previously untreated, and eligible for treatment with intensive chemotherapy as defined by the following: Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina. Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume during the first second (FEV1) ≤ 65%. Creatinine clearance \< 45 mL/min. Moderate hepatic impairment with total bilirubin \> 1.5 × ULN. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy.
- Patients \> 18 to ≤ 60 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2
- Laboratory values meeting the following criteria:Creatinine clearance ≥ 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Serum aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN) 、Serum alanine aminotransferase (ALT) ≤ 3.0 × ULN (Unless considered due to leukemic organ involvement), Total bilirubin ≤ 1.5 × ULN, White blood cell (WBC) count \< 25 × 109 /L (hydroxyurea is permitted to meet this criterion)
Age in the registry: 18 years to 60 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 |
|---|---|---|---|
| Qiu huiying Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.