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MRD Response-adapted Allo-HSCT for Adverse-risk AML

NCT06301425 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2024-07-10

No results posted yet for this study

Summary

This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial.

Conditions

Interventions

OTHER

Intervention group

Patients in interventional group could choose one of the following treatment protocols and then receive allo-HSCT if they were CR after the second consolidation: 1. . Venetoclax plus azacitidine: azacitidine 75mg/m2/d d1-7; venetoclax 400mg/d, d1-21; 2. . Venetoclax plus CAG: venetoclax 400mg qd d1-14; aclacinomycin 20mg qd d1-4; cytarabine 10mg/m2 q12h subcutaneous injection d1-14; G-CSF 300μg qd d1-14; 3. . Venetoclax plus IA: venetoclax 400mg qd d1-4; idarubicin 10mg qd d1-4; cytarabine 500mg qd d1-4; 4. . Venetoclax plus AA: venetoclax 400mg qd d1-7; aclacinomycin 20mg qd d1-7; cytarabine 100mg/m2 qd d1-7.

OTHER

Control group

Receive allo-HSCT directly without the second consolidation chemotherapy.

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • Wuhan TongJi Hospital

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiaodong Mo · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2027-05-01
Completion
2028-05-01

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 NCT06301425 on ClinicalTrials.gov