Efficiency, Safety Issues
Conditions
Keywords
Cord blood microtransplatation
Brief summary
Discuss the effectiveness and safety of cord blood microtransplantation for treatment of acute myeloid leukemia
Detailed description
The investigators conducted a prospective, single center clinical trial to dissuss the outcomes and toxicities of HLA-mismatched cord blood infusion after chemotherapy (microtransplantation) in older patients with acute myeloid leukemia (AML)
Interventions
BIOLOGICALmicrotransplantation
HLA mismatched donor cord blood infusion
Sponsors
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. de novo acute myeloid leukemia 2. age 60-80
Exclusion criteria
1. have no suitable donor or donor refused 2. patient refused to accept donor cells
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | 1 month | Bone marrow \<5% blasts； Absolute neutrophil count \>1000/mcL； Platelets ≥100,000/mcL；No residual evidence of extramedullary disease. |
| time of hematopoietic recovery | 1 month | Absolute neutrophil count \>500/mcL; Platelets ≥20,000/mcL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to progression | 2 year | Measured from complete remission to the relapse |
Other
| Measure | Time frame | Description |
|---|---|---|
| diease free survival | 2 year | Measured from complete remission to the date of death or the date of last follow-up examination. |
| overall survival | 2 year | Measured from the date of beginning therapy to the date of death or the date of last follow-up examination. |
| rate of early mortality | 1 month | Death within 4 weeks after initiation of induction therapy |
Countries
China
Contacts
Primary ContactWen Yao
Outcome results
None listed