Relapsed and Refractory Acute Myeloid Leukemia
Conditions
Interventions
treatment group:Compound Fritillaria thunbergii Bulb Granules combined with VA regimen
control group:VA regimen
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Age between 18 and 75 years old; 2)Meeting the diagnostic criteria for relapsed and refractory acute myeloid leukemia: reappearance of leukemia cells in the peripheral blood or = 5% blasts in the bone marrow after complete remission (CR) of AML (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy) or infiltration of leukemia cells outside the bone marrow; newly diagnosed cases that are ineffective after 2 courses of standard treatment; relapse within 12 months after CR after consolidation and intensive treatment; relapse after 12 months but ineffective after conventional chemotherapy; two or more relapses; persistent extramedullary leukemia; 3)Meeting the diagnostic criteria for the syndrome of phlegm and blood stasis mutual obstruction: dull complexion masses ecchymoses or petechiae (on the skin) bone pain dizziness fatigue poor appetite low fever dark tongue greasy tongue coating slippery or astringent pulse; 4)Unable to tolerate or refusing intensive chemotherapy; 5)Having no indication for targeted drugs or refusing targeted drug treatment; 6)Voluntarily signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1)Patients with early relapse after previous treatment with VEN (venetoclax) + HMA (hypomethylating agents); 2)Patients with other severe hematological or non-hematological tumors; 3)Patients with relatively severe organic lesions such as those in the cardiovascular and cerebrovascular systems liver and kidneys; 4)Pregnant or lactating women; 5)Patients with mental disorders who cannot cooperate with the treatment; 6)Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Single-Cell Sequencing;Relapse-Free Survival;Patient-Reported Outcomes in Acute Leukemia;Drug Resistance-Associated Proteins;Overall Survival;Progression-Free Survival;Evaluation of Therapeutic Efficacy of TCM Syndromes;Minimal Residual Disease; | — |
Countries
China
Contacts
Public ContactLang Haiyan
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed