Acute Myeloid Leukemia
Conditions
Interventions
Experimental group:Homoharringtonine: 2mg/m2, IV, d1-7
Cytarabine: 10mg/m2 q12h, IV, d1-14
Human Granulocyte Colony-Stimulating Factor (G-CSF) : 5µg/kg, subcutaneous injection, d1-14, discontinue if p
Specification: 100g
Approval Number: YBH07082021)
Erlotinib: 150mg, oral, d1-28, reduce dosage based on condition if used concurrently with CYP3A4 inhibitors (Erlotinib dosage for solid tumors is indicated as 150mg/day)
Specification: 150mg
Approval Number: H20170143).
Sponsors
The second affiliated hospital of the army medical university
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Clinically diagnosed AML excluding acute promyelocytic leukemia; 1)Relapsed AML: Reappearance of leukemic cells in the peripheral blood or =5% blasts in the bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemic cell infiltration after complete remission (CR) of AML. 2)MRD relapsed AML: Conversion from MRD negative to MRD positive; 3)Refractory AML (meeting one of the following criteria): a) Newly diagnosed AML that are ineffective after two cycle of standard regimen treatment; b) Relapse within 12 months after achieving CR and undergoing consolidation therapy; c) Relapse after 12 months and ineffective after conventional chemotherapy; d) Two or more relapses; e) Persistent extramedullary leukemia. 5)Failure to achieve CR/CRi aftrer one cycle of induction therapy; (2) The date of relapse or refractory is defined as the sampling date on the first bone marrow cytogenetic or molecular report. (3) Age: 18-70 years (inclusive of the boundary values 18 and 70); (4) ECOG score: =50% on echocardiogram; (6) No other immunotherapy received within the last 3 months; (7) Female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use highly effective contraception throughout the study and for at least four months after the last dose of study treatment. (8) Laboratory results indicating: bilirubin <= 1.5 mg/dL; ALT/AST <= 2.5 times the upper limit of normal; creatinine <= 1.5 mg/dL (this criterion may be ignored if the patient has liver or kidney damage due to leukemia).
Exclusion criteria
Exclusion criteria: (1) Uncontrolled infection (within 7 days prior to initiation of treatment) (2) Active hepatitis B/C infection (3) HIV infection (4) Congenital immunodeficiency (5) Inability to swallow tablets, or impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of erlotinib (e.g., history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), celiac disease, prior gastrectomy, or any other gastrointestinal disease or defect that would interfere with the absorption, distribution, metabolism, or excretion of the study drug and/or increase the risk of gastrointestinal toxicity in the subject) (6) Concurrent malignancies requiring treatment other than basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast (7) Patients previously treated with HAG regimens or erlotinib (8) Participation in other clinical studies (9) Presence of psychiatric disorders (10) Patients with known allergies or contraindications to the study drug (active pharmaceutical ingredient and/or excipients) (11) Any other condition that, in the judgment of the investigator, would preclude the patient from participating in the clinical study due to safety concerns or compliance with clinical study procedures.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Progression-Free Survival (PFS);Duration of Response (DOR);Adverse Events (Safety);Overall Response Rate (ORR) and Minimal Residual Disease (MRD) Negativity Rate.;Different Cytogenetic and Molecular Responses; | — |
Primary
| Measure | Time frame |
|---|---|
| The modified composite complete remission (mCRc) rate.; | — |
Countries
China
Contacts
Public ContactWen Qin
The second affiliated hospital of the army medical university
Outcome results
None listed