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A multicentered, randomized, controlled study, assessing the effecacy and safety of DAC-CAG regimen in combination with HLA mismatched mononuclear cell infusion in the elderly acute myeloid leukemia

A multicentered, randomized, controlled study, assessing the effecacy and safety of DAC-CAG regimen in combination with HLA mismatched mononuclear cell infusion in the elderly acute myeloid leukemia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17010830
Enrollment
Unknown
Registered
2017-03-10
Start date
2017-02-27
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

acute myeloid leukemia

Interventions

Research Group:DAC-CAG regimen in combination with HLA mismatched mononuclear cell infusion

Sponsors

Department of Hematology, Tangdu Hospital, Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 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 50-70 years; 3. ECOG score 0-2; 4. The expected survival time more than 3 months; 5. Main organ function: serum bilirubin is less than or equal to 1.5 ULN, ALT and AST is less than or equal to 2.5 ULN, serum Cr is less than or equal to 1.5 ULN; 6. subjects volunteered to try and signed the informed consent, signed informed consent process to meet the requirements of GCP.

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

MeasureTime frame
complete remission rate;

Secondary

MeasureTime frame
overall survival;Relapse free survival;overall response rate;Early mortality;Transfusion dependent remission rate;

Countries

China

Contacts

Public ContactLiu Li

Department of Hematology, Tangdu Hospital, Fourth Military Medical University

liuli1@medmail.com.cn+86 029 84777841

Outcome results

None listed

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