Efficacy and safety of DAC-CAG regimen: an open-label, prospective study in the primary elderly acute myeloid leukemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-OPC-17011225

Enrollment

Unknown

Registered

2017-04-23

Start date

2017-05-01

Completion date

Unknown

Last updated

2017-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myeloid leukemia

Interventions

DAC-CAG :DAC-CAG regimen

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Morphological, genetic, and flow cytometry confirmed acute myeloid leukemia with the standard of diagnosis and treatment of blood diseases; 2. Aged 50-80 years; 3. ECOG score 0-3; 4. The expected survival time more than 3 months; 5. Main organ function is normal; 6. subjects volunteered to try and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Retreatment patients; 2. Patients with allogeneic hematopoietic stem cell transplantation indications and willingness to transplant; 3. Patients diagnosed as acute premyelocyte leukemia; 4. Patients with central nervous system involvement; 5. Can not be drawn from the bone marrow; 6. Any time treated with azacitidine or decitabine; 7. Diagnosed with other malignant tumors in the previous 12 months; 8. Systematic fungal, bacterial or viral infection (defined as the symptom and signs are associated with infection, despite the use of antibiotics or other treatment, which are still not improved); 9. Known or suspected to be allergic to DEC; 10. Contraindications to anthracycline chemotherapy; 11. Human immunodeficiency virus (HIV) or hepatitis B virus infection; 12. Previous history of definite neurological or psychiatric disorders, including epilepsy or dementia; 13. According to the researcher's judgment, there is a serious harm to the patient safety, or the impact of patients with the completion of the study of concomitant diseases; 14. Participated in other clinical trials; 15.Can not comply with research programme.

Design outcomes

Primary

Measure	Time frame
overall survival;	—

Secondary

Measure	Time frame
complete remission rate;Relapse free survival;overall response rate;Early mortality;Transfusion dependent remission rate;The relationship between OS and CR rate with cytogenetic abnormal and genetics abnormal;	—

Countries

China

Contacts

Public ContactLi Guohui

Department of Hematology, Tangdu Hospital, Fourth Military Medical University

lghab@126.com+86 13892888604

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026