Relapsed/refractory acute myeloid leukemia
Conditions
Interventions
CHAG:Cladribine + HAG
Sponsors
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 60; 2. Diagnosed with relapsed or refractory AML; (1) Relapsed AML is defined as recurrence of leukemia cells in peripheral blood, blast cells in bone marrow > 5%, or new extramedullary infiltration after achieving complete remission (CR); (2) Refractory AML is defined as : Failed to achieved CR after at least 1 courses of standard induction chemotheapy; Relapse within 12 months after consolidation therapy after CR; Relapse after 12 months but unresponse to conventional chemotherapy; Second or more relapse; Persistence of extramedullary leukemia; 3. Eastern Cooperative Oncology Group (ECOG) score 0 to 2; 4. Alanine aminotransferase (ALT) = 50 mL/min.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia (APL); 2. Human immunodeficiency virus (HIV) infection (HIV antibody positive); active Hepatitis B virus (HBV) and hepatitis C virus (HCV) infection; 3. New York Heart Association cardiovascular disability status > 2; 4. Chronic respiratory diseases that require continuous oxygen inhalation, or a history of obvious renal, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases; 5. Uncontrollable systemic infection; 6. Allergic to any agent in the treatment regimen; 7. Pregnant or lactating women; 8. Any other conditions that the investigator think unsuitable to participate this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response (CR+CRi) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Overall survival (OS);Disease free survival (DFS); | — |
Countries
China
Contacts
Public ContactXu Shuangnian
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Outcome results
None listed