Skip to content

Venetoclax combined with medium-dose cytarabine as consolidation therapy after standard induction chemotherapy in patients with Fit AML: a multicenter, prospective, observational clinical study

Venetoclax combined with medium-dose cytarabine as consolidation therapy after standard induction chemotherapy in patients with Fit AML: a multicenter, prospective, observational clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090947
Enrollment
Unknown
Registered
2024-10-16
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

AML

Interventions

Venetoclax combined with medium-dose cytarabine :None

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1: Age 18-59, male and female. 2: Adult patients with AML (non-APL) who can tolerate intense chemotherapy and who have achieved CR/CRi after induction chemotherapy but MRD-positive are treated with consolidation therapy using Venetoclax in combination with medium-dose cytarabine. 3: Patients with concomitant FLT3 mutations can be treated with the addition of targeted agents. 4: Subjects voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1: Patients have a history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, true erythrocytosis, chronic myelogenous leukemia (CML), and AML with BCR-ABL1 translocation or acute promyelocytic leukemia (APL). 2: Secondary AML with a history of MDS 3: Central nervous system infiltration with active leukemia 4: Clinically uncontrolled active infection and organ hemorrhage 5: Combination of severe abnormalities of vital organ function and other malignant tumors 6: Mental disorders that would prevent research participation 7: Patients who are pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
MRD conversion rate;

Secondary

MeasureTime frame
DOR, EFS, OS;TRM;

Countries

China

Contacts

Public ContactChunyan Chen

Qilu Hospital of Shandong University

chency@sdu.edu.cn+86 185 6008 7023

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026