Measurable Residual Disease Response-adapted Allogeneic Hematopoietic Stem Cell Transplantation for Adverse-risk Acute Myeloid Leukemia: an Open-label, Randomized, Controlled Trial（TROPHY-AML01）
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 65
Healthy Volunteers: f
View:
• Newly diagnosed AML;
• Categorized into adverse-risk group according to ELN 2022 criteria;
• 16-65 years of age at the time of diagnosis;
• achieving CR after 1 or 2 courses of induction chemotherapies;
⁃ 4\) ECOG PS score of 0 to 1 5) It needs consent from the patients or/and legal guardian, and signature on the Informed Consent.
Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Xiaodong Mo
moxiaodong@pkuph.edu.cn
86-10-88326001
Backup
Xiaoxia Hu
hxx12276@rjh.com.cn
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 178
Treatments
Experimental: Intervention group
According to the MFC MRD status after the first consolidation (MRDcon1), the MRDcon1 positive patients were categorized into high-risk group (i.e., risk stratification). All the patients in high-risk group who fulfilled all inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive a second consolidation therapy (intervention group) or receive allo-HSCT directly (control group).
Active_comparator: Control group
According to the MFC MRD status after the first consolidation (MRDcon1), the MRDcon1 positive patients were categorized into high-risk group (i.e., risk stratification). All the patients in high-risk group who fulfilled all inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive a second consolidation therapy (intervention group) or receive allo-HSCT directly (control group).
Related Therapeutic Areas
Sponsors
Collaborators: Anhui Provincial Hospital, Ruijin Hospital, Wuhan TongJi Hospital
Leads: Peking University People's Hospital