Effectiveness of Medium-Dose Cytarabine Combined With Venetoclax for Consolidation Therapy in Elderly Patients With Intermediate to High-Risk Acute Myeloid Leukemia

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60-75
SponsorYehui Tan

About this trial

A Single-center, Single-arm, Prospective Clinical Study of Intermediate-dose Cytarabine in Combination with Venetoclax for Consolidation Therapy of Middle- and High-risk Acute Myeloid Leukemia in the Elderly

Eligibility criteria

Qualifiers

Total bilirubin ≤ 1.5 times the upper limit of normal for the same age group;

AST and ALT ≤ 2.5 times the upper limit of normal for the same age group;

Serum creatinine < 2 times the upper limit of normal for the same age group;

Cardiac ejection fraction within normal limits as determined by echocardiogram. 9.Able to comply with the study visit schedule and understand and adhere to all trial protocol requirements; 10.Able to take oral medications.

Disqualifiers

Allergic to any drugs included in the trial protocol or drugs with a chemical structure similar to the investigational drug.

Chemotherapy intolerance assessed by Ferrara 2013 criteria prior to enrollment.

Hematologic relapse (bone marrow blasts or immature cells exceed 5%).

Simultaneous diagnosis of other malignant tumors in organs (requiring treatment).

Trial design

Treatments tested in this trial

  • Intermediate-dose Cytarabine in Combination with Venetoclax

Treatment groups

68 Participants
are divided into 1 treatment group

Sponsors and collaborators

Yehui Tan

Lead sponsor

The First Hospital of Jilin University

Sponsor institution