MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Blood Diseases Hospital
RECRUITING
Tianjin
Contact Information
Primary
Hui Wei, Doctor
weihui@ihcams.ac.cn
13132507161
Time Frame
Start Date: 2024-05-11
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 120
Treatments
Experimental: With lDH1 gene mutation
Ivosidenib 500mg/d d1-28 ;Azacitidine 75mg/m2/d d1-7;Venetoclax400mg/d:d1-28
Experimental: FLT3 gene mutation
Gilteritinilb 120mg/d, d1 -28; Venetocax 400mg/d d1-28 400mg
Experimental: NPM1 mutation or IDH2 mutation
Azacitidine 75mg/m2/d d1-7;Venetoclax400mg/d d1-21 or Cytarabine 20mg/m2/d d1-10;Venetoclax 600mg/d d1-21
Experimental: c-kit mutation
Avapritinib 200mg/ day, 28 days a course
Experimental: Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax
Cytarabine 100mg/m2/d, d1-5; Daunorubicin 45mg/m2/d,d1-2;or Idarubicin 10mg/ m2/d,d1-2;or MTZ 8mg/ m2/d d1-2; Venetoclax 400mg d1-7
Experimental: Cytarabine+HHT+Venetoclax
Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7
Experimental: Venetoclax+Azacitidine/Venetoclax+Cytarabine
Azacitidine75 mg/m2 day1-7;Venetoclax 400mg day1-21 or,Cytarabine 20mg/m2 /day,day1-10; Venetoclax 600mg day1-21
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

Similar Clinical Trials