NCT06763666Not yet recruitingPhase 4
CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML
A Multicenter, Prospective, Randomized Controlled Study Comparing the Efficacy and Safety of CLAG(Cladribine, Cytarabine and G-CSF) Combined With Venetoclax and CLAG in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 8 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a multicenter, prospective, randomized controlled clinical study comparing the efficacy and safety of CLAG+VEN and CLAG regimens in relapsed/refractory(r/r) AML.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- First submitted
- 30 Dec 2024
- Start date
- Feb 2025
- Primary completion date
- Jun 2025
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06763666
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 172
- From Feb 2025 to the primary completion date, Jun 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.
Other illness
- Cardiac function \< grade 2.
- Known human immunodeficiency virus (HIV) infection.
- Other clinically significant uncontrolled conditions, including but not limited to: a. uncontrolled or active systemic infections (viruses, bacteria, or fungi); b. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; c. Secondary tumors requiring active treatment.
- Allergy to experimental drugs.
Other
- Diagnosed of acute promyelocytic leukemia (AML-M3)
- Patients with central nervous system (CNS) invasion.
- Pregnant and lactating women.
- Patients who ineligible for the study according to the investigator's assessment.
Who the study is looking for
- Diagnosed of AML according to the World Health Organization (WHO) classification.
- All patients should aged 18 to 65 years.
- Diagnosed of relapsed and refractory AML, according to The guidelines for diagnosis and treatment of relapse /refractory acute myelogenous leukemia in China（2023）
- Diagnostic criteria for relapsed AML: Leukemia cells reappear in the peripheral blood or primitive cells in the bone marrow ≥ 5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) after CR, or leukemia cell infiltration appears outside the marrow.
- Diagnostic criteria for refractory AML: The newly diagnosed patients who failed to respond to two courses of standard treatment; Patients who relapsed within 12 months after consolidation intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.
- The score of Eastern Cooperative Oncology Group (ECOG) is 0-2.
- Renal function: creatinine clearance rate ≥ 30ml/min.
- Liver function: ALT\<5 times normal value, bilirubin\<3 times normal value.
- Predicted survival ≥ 3 months.
- Able to accept oral Venetoclax.
- Sign an informed consent form and be able to understand and follow the procedures required by this protocol.
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 |
|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.