acute myeloid leukemia
Conditions
Interventions
Group A:Venetoclax 100mg d1, 200mg d2, 400mg d3-d21, qd, oral
Azacitidine 75mg/m2, d1-d7,subcutaneous injection
G-CSF:5ug/kg/d,d1-d7
Group B:Venetoclax 100mg d1, 200mg d2, 400mg d3-d28, qd, oral
Azacitidine 75mg/m2, d1-d7,subcutaneous injection.
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Subject must have confirmation of AML by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or co-morbidities. 2)Patients aged >= 75 years, or aged 60-74 years with one of the following diseases: ECOG score 2-3; History of congestive heart failure or EF =30ml/min, 1.5 times the upper limit of normal, =75 years, score 0-2. Aged 60-74 years, score 0-3. 4)Adequate liver and renal function are required: Blood bilirubin 50% 6).Life expectancy is at least 12 weeks. 7).Obtain informed consent signed by the patient or family member.
Exclusion criteria
Exclusion criteria: 1.Subject has acute promyelocytic leukemia (APL). 2.Subject has a history of other malignancies within the past two years prior to study entry, with the exception of: ? Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; ? Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; ? Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent. 3.Subject is known to be positive for HIV 4.Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required). Subjects with serologic evidence of prior vaccination to HBV [i.e., HBs Ag-, and anti-HBs+-] may participate). 5.Other serious diseases that may restrict patients from participating in this test, such as advanced infection, uncontrollable diabetes, severe cardiac insufficiency or angina. 6.Unable to understand or follow the research protocol. 7.Subject has history of myeloproliferative neoplasm [MPN], myelodysplastic syndrome (MDS). 8.Subjects who are unable to take oral medication or have malabsorption syndrome. 9.Has previously received treatment with venetoclax and/or is currently involved in any other research using the investigational drug. 10.Unable to sign an informed consent form. 11.Subject has known active CNS involvement with AML 12.Subject has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment. 13.Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment. 14.Subject has a white blood cell count > 25 × 109/L. (Hydroxyurea is permitted to meet this criterion.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission;Composite complete remission;Minimal residual disease negative conversion rate;Disease-free Survival;Event-free Survival;Safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactZhu Honghu
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed