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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: f
View:

• Age ≥ 60 years and ≤ 75 years, regardless of gender; 2.Diagnosed with AML (acute myeloid leukemia) according to WHO criteria (non-acute promyelocytic leukemia); 3.Risk stratification as intermediate or high risk based on the ELN (2022) guidelines; 4.Expected survival time ≥ 3 months; 5.Not suitable for allogeneic hematopoietic stem cell transplantation; 6.AML patients who achieve remission with morphologic assessment of bone marrow showing no leukemic involvement after induction therapy; 7.Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2; 8.Meeting the following laboratory requirements (performed within 7 days prior to treatment):

⁃ 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.

Locations
Other Locations
China
The First Hospital of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Yehui Tan
yhtan@jlu.edu.cn
+8615948027438
Backup
Yuying Li
lyying1001@jlu.edu.cn
+8613944135650
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 68
Treatments
Experimental: Middle-and High-risk Acute Myeloid Leukemia in the Elderly
Related Therapeutic Areas
Sponsors
Leads: Yehui Tan

This content was sourced from clinicaltrials.gov