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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.
Patients aged 14 years or older with diagnosed AML (non-M3) who have achieved complete remission in bone marrow morphology but are positive for minimal residual disease by flow cytometry or have the following genetic mutations that can be detected by PCR: NPM1 mutation, IDH1/2 mutation, DEK-NUP214 (DEK-CAN), RUNX1-RUNX1T1(AML 1-ETO), or CBFβ-MYH 11[4]. NGS can detect mutations such as FLT3.
For eligible patients, the treatment plan is selected by the doctor in charge according to the specific conditions of the patient. During the treatment, patients can have hematopoietic stem cell transplantation at any time.
This study compared relapse-free survival and overall survival of MRD-positive patients after effective and persistent MRD treatment, and based on the results, observed the efficacy and safety of different treatment regiments for MRD-positive AML patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With lDH1 gene mutation | Experimental | Ivosidenib 500mg/d d1-28 ;Azacitidine 75mg/m2/d d1-7;Venetoclax400mg/d:d1-28 |
|
| FLT3 gene mutation | Experimental | Gilteritinilb 120mg/d, d1 -28; Venetocax 400mg/d d1-28 400mg |
|
| NPM1 mutation or IDH2 mutation | Experimental | Azacitidine 75mg/m2/d d1-7;Venetoclax400mg/d d1-21 or Cytarabine 20mg/m2/d d1-10;Venetoclax 600mg/d d1-21 |
|
| c-kit mutation | Experimental | Avapritinib 200mg/ day, 28 days a course |
|
| Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivosidenib | Drug | 500mg d1-28 |
| |
| Gilteritinib |
| Measure | Description | Time Frame |
|---|---|---|
| relapse-free survival rate | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurable Residual Disease | up to 6 months | |
| Proportion of MRD turning negative | up to 6 months | |
| Overall survival(OS ) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Wei, Doctor | Contact | 13132507161 | weihui@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huui Wei, doctor | Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000627630 | ivosidenib |
| C000609080 | gilteritinib |
| C579720 | venetoclax |
| C000707147 | avapritinib |
| D003630 | Daunorubicin |
| D003561 | Cytarabine |
| D015255 | Idarubicin |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Cytarabine+HHT+Venetoclax |
| Experimental |
Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7 |
|
| Venetoclax+Azacitidine/Venetoclax+Cytarabine | Experimental | Azacitidine75 mg/m2 day1-7;Venetoclax 400mg day1-21 or,Cytarabine 20mg/m2 /day,day1-10; Venetoclax 600mg day1-21 |
|
| Drug |
120mg d1-28 |
|
| Venetoclax | Drug | 400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21 |
|
| Avapritinib | Drug | 200mg d1-28. |
|
| Daunorubicin | Drug | 45mg/m2/d d1-2; |
|
| Cytarabine | Drug | 100mg/m2/d d1-5 |
|
| Idarubicin | Drug | 10mg/m2/d d1-2 |
|
| MTZ | Drug | 8mg/m2/d d1-2 |
|
| HHT | Drug | 2mg/m2/d d1-5 |
|
| Azacitidine | Drug | 75mgd/m2 d1-7. |
|
| From the time the patients participated in the clinical trial until the patient died |
| Cumulative relapse rate | From the time the patients participated in the clinical trial until the patient relapsed |
| Adverse Events (AEs) | up to 2 years |
| The incidence of adverse events such as serious infections during treatment | up to 2 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D001372 | Aza Compounds |
| D012263 | Ribonucleosides |