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Not Yet Recruiting NCT07642453

VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.

Conditions: Acute Myeloid Leukemia (AML)

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 110
Sponsor: Hematology department of the 920th hospital

Summary

Objective: This clinical trial aims to compare the efficacy and safety of the VA-CAG regimen administered as a two-week schedule versus a three-week schedule for induction remission in acute myeloid leukemia (AML). Key Research Questions: 1. Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML? 2. Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and/or fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.

Eligibility Criteria

Inclusion Criteria: 1. Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines; 2. Age 18-75 years; 3. Body weight 30-100 kg; 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3; 5. No significant organ dysfunction (echocardiographic ejection fraction \>45%; bilirubin \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07642453). StuddyBuddy aggregates publicly available trial information.