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A Prospective Multicenter Phase II Study on CD69 Expression as a Predictor of Efficacy for Lisaftoclax  Combined with Chemotherapy in Treatment-Naïve Acute Myeloid Leukemia

A Prospective Multicenter Phase II Study on CD69 Expression as a Predictor of Efficacy for Lisaftoclax  Combined with Chemotherapy in Treatment-Naïve Acute Myeloid Leukemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117988
Enrollment
Unknown
Registered
2026-01-30
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Interventions

Low risk group/mediun-to-high risk group:Lisaftoclax combined with Ara-C and Idarubicin

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Voluntarily sign the informed consent form; 2.Age >= 18 years; 3.Adequate hepatic and renal function: Serum bilirubin =50%, New York Heart Association functional classification NYHA I/II); 5.Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale; 6.Non-pregnant and non-lactating women; 7.For all women of childbearing potential, a negative pregnancy test (hCG) is required to rule out pregnancy; 8.For all men of childbearing potential, contraception must be used during treatment with lissatoclax and for 3 months after the last dose.

Exclusion criteria

Exclusion criteria: 1. Allergy or contraindication to any drug involved in the regimen; 2. Liver and kidney functions are significantly abnormal, exceeding the inclusion and exclusion criteria; 3. Heart disease: including echocardiographic EF 2), ECG QTc >470 ms; 4. Pulmonary disease: pulmonary edema, pleural effusion (CTCAE score >2); 5. Participation in other clinical studies at the same time.

Design outcomes

Primary

MeasureTime frame
Complete response rate;

Secondary

MeasureTime frame
Minimal residual disease negative rate;Cumulative recurrence rate;Event-free survival;Overall survival rate;

Countries

China

Contacts

Public ContactSongfu Jiang

The First Affiliated Hospital of Wenzhou Medical University

jiangsongfu@189.cn+86 153 0577 0033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026