Clinical Trial Protocol for the Combined Use of VAG in the Treatment of ND-AML

Sponsor
Yang Xiaotian
Study ID
NCT06536010
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a clinical efficacy study evaluating the VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML). The main objectives of the study are to assess the efficacy and safety of the VAG regimen and to explore the synergistic mechanisms of VAG in combating AML.

Key Dates

Start date
Nov 3, 2021
Status verified
Jul 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VAG regimen in the treatment of newly diagnosed acute myeloid leukemia (AML)
    AZA: 75mg/m2 on days 1-7 VEN: 100mg on day 1, 200mg on day 2, 400mg on days 3-28 G-CSF: 50-600ug/day, starting on day 1 (adjusted based on WBC count of 10-25\*10E9/L) In the induction phase of the ND-AML treatment protocol, VEN+AZA+G-CSF is administered. At the end of the induction phase, the efficacy is evaluated. If the patient achieves complete remission (CR), the original treatment protocol is continued for consolidation. If the patient achieves partial remission (PR), the original treatment protocol is repeated for induction until the patient achieves CR or shows no response (NR), progressive disease (PD), or relapse (PR/NR/PD). If the patient shows no response or progressive disease, the study is concluded.

Primary Outcome Measure

Complete Remission (CR) [ Time Frame: The period of 2 months from the start of treatment. ]

Central Contacts

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