MRD-positive AML Clinical Study
MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study
Institute of Hematology & Blood Diseases Hospital, China
120 participants
May 11, 2024
INTERVENTIONAL
Conditions
Summary
This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.
Eligibility
Inclusion Criteria4
- AML (non-M3) compliant with WHO (2016) standards;
- In morphological complete remission.
- Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.
- Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Exclusion Criteria3
- Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks
- The diagnosis is APL
- Those who were not considered suitable for inclusion by the researchers.
Interventions
45mg/m2/d d1-2;
100mg/m2/d d1-5
10mg/m2/d d1-2
8mg/m2/d d1-2
2mg/m2/d d1-5
75mgd/m2 d1-7.
500mg d1-28
120mg d1-28
400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21
200mg d1-28.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07131059