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Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML

NCT06232694 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-01-31

No results posted yet for this study

Summary

This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML).

This study includes the induction and consolidation phases of AML treatment.

Conditions

Interventions

DRUG

Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;

Induction Phase Regimen

DRUG

Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;

Consolidation therapy after remission

OTHER

utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Four cycles in total.Patients who meet the criteria for autologous stem cell transplantation (ASCT) during the treatment process can undergo ASCT.Patients who meet the transplantation criteria and have a suitable donor can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Sponsors & Collaborators

  • Huai'an First People's Hospital

    collaborator OTHER

  • Yancheng First People's Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06232694 on ClinicalTrials.gov