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Trial Title:
MRD Response-adapted Allo-HSCT for Adverse-risk AML
NCT ID:
NCT06301425
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Acute myeloid leukemia
Allogeneic hematopoietic stem cell transplantation
Measurable residual disease
Adverse risk
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Intervention group
Description:
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.
Arm group label:
Intervention group
Intervention type:
Other
Intervention name:
Control group
Description:
Receive allo-HSCT directly without the second consolidation chemotherapy.
Arm group label:
Control group
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.
Detailed description:
1.1 Relapse is the most important cause of transplant failure Acute myeloid leukemia is
one the most important hematologic malignancies for adults. According to the criteria of
European LeukemiaNet (ELN) 2022, approximately 40%-50% of AML patients were categorized
into adverse-risk group. The clinical outcomes of these patients receiving chemotherapy
alone is poor and the 4-year probability of leukemia-free survival (LFS) after therapy is
nearly 10%. Thus, allogeneic hematologic stem cell transplantation (allo-HSCT) is
considered as the critical consolidation in adverse-risk AML patients, and many AML
patients could achieve long-term LFS after allo-HSCT. However, nearly one third of the
adverse-risk AML patients would experience relapse after allo-HSCT, and the outcomes of
patients with post-transplant are very poor and relapse is also the most important cause
of mortality after allo-HSCT. Thus, how to prevent post-transplant relapse is important
to further improve the survival of patients with adverse-risk AML.
1.2 Measurable residual disease (MRD) can predict the relapse of AML after treatment.
The detection of MRD is one of the most important methods for defining the depth of
remission. Using current sensitive techniques, the presence of 1 residual leukemia cell
in 10 000-1 000 000 cells can be detected in patients with morphological complete
remission (CR). The most commonly used method for MRD assessment involves (1) the
determination of leukemia-associated immunophenotypic patterns (LAIPs) using
multiparameter flow cytometry (MFC) and (2) the quantitative polymerase chain reaction
(qPCR)-based evaluation of expression levels of leukemia-related genes, such as recurrent
genetic abnormalities and other mutation types.
1.3 Pre-transplant MRD can predict the relapse of AML after allo-HSCT. MFC is one of the
most common methods for MRD monitoring and is the most important method for MRD
monitoring for those without leukemia-specific molecular markers. In the systemic review
of Buckley et al., pre-transplant MRD was associated with worse LFS (hazard ratio [HR] =
2.76 [1.90-4.00]), overall survival (OS, HR = 2.36 [1.73-3.22]), and cumulative incidence
of relapse (HR = 3.65 [2.53-5.27]).
1.4 The prognostic value of pre-transplant MRD positivity is controversial in
adverse-risk AML.
Pre-transplant MRD positivity could predict relapse after allo-HSCT, however, its
prognostic value may be more significantly in patients with favorite- and
intermediate-risk group. Some authors suggested that pre-transplant MFC MRD was less
important in predicting relapse than variables reflecting the biology of the disease
(e.g., cytogenetics, molecular marker, or chemotherapy refractory). Receiving repeated
consolidation to achieve pre-transplant MRD negativity may not decrease the risk of
relapse and improve survival, and patients may experience relapse during consolidation
chemotherapy and may suffer additional therapeutic toxicities which may increase the risk
of non-relapse mortality after allo-HSCT.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly diagnosed AML;
2. Categorized into adverse-risk group according to ELN 2022 criteria;
3. 16-65 years of age at the time of diagnosis;
4. 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.
Exclusion Criteria:
1. Newly diagnosed AML, but categorized into favorite- or intermediate-risk group
according to ELN 2022 criteria;
2. < 16 years, or older than 65 years at the time of diagnosis;
3. Achieving CR after 3 or more courses of induction chemotherapies, or could not
achieve CR after induction chemotherapies;
4. ECOG PS score of 2 or more;
5. 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.
Gender:
All
Minimum age:
16 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaodong Mo
Email:
mxd453@163.com
Start date:
May 24, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan TongJi Hospital
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06301425