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

NCT06301425 | Recruiting

• 1 other identifier: TROPHY-AML01
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia; Allogeneic hematopoietic stem cell transplantation; Measurable residual disease; Adverse risk

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

  EFS, defined as the time from the date of randomization to the date of MRD positivity, relapse, or death due to any cause.

  1 year

Secondary Outcomes (6)

• Relapse

  1 year

• Leukemia-free survival (LFS)

  1 year

• Non-relapse mortality (NRM)

  1 year

• Overall survival (OS)

  1 year

• Acute graft-versus-host disease (aGvHD)

  1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Other: Intervention group

Control group

ACTIVE COMPARATOR

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).

Other: Control group

Interventions

Intervention group OTHER

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.

Intervention group

Control group OTHER

Receive allo-HSCT directly without the second consolidation chemotherapy.

Control group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed AML;
• Categorized into adverse-risk group according to ELN 2022 criteria;
• years of age at the time of diagnosis;
• achieving CR after 1 or 2 courses of induction chemotherapies;
• \) ECOG PS score of 0 to 1 5) It needs consent from the patients or/and legal guardian, and signature on the Informed Consent.

You may not qualify if:

• Newly diagnosed AML, but categorized into favorite- or intermediate-risk group according to ELN 2022 criteria;
• \< 16 years, or older than 65 years at the time of diagnosis;
• Achieving CR after 3 or more courses of induction chemotherapies, or could not achieve CR after induction chemotherapies;
• ECOG PS score of 2 or more;
• Patients with other comorbidities or mental diseases that influence the life safety and compliance of patients as well as affect informed consent, enrollment in the research, follow-up visit or result interpretation.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Ruijin Hospital: collaborator
• Wuhan TongJi Hospital: collaborator
• Anhui Provincial Hospital: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xiaodong Mo

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaodong Mo

CONTACT

86-10-88326001; moxiaodong@pkuph.edu.cn

Xiaoxia Hu

CONTACT

hxx12276@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 8, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

CN (1)