Leukemia, Myeloid
Conditions
Keywords
Acute Myeloid Leukemia, Relapsed, Refractory, hematopoietic stem cell
Brief summary
The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.
Detailed description
The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells. no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.
Interventions
BIOLOGICALhematopoietic stem cell
high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
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
15 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient with relapsed and/or refractory AML * Estimated life expectancy ≥ 12 weeks (according to investigator's judgment) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion criteria
* Previous treatment with investigational gene or cell therapy medicine products * Any uncontrolled active medical disorder that would preclude participation as outlined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 2 years | — |
| Overall survival | 2 years | — |
| donor graft rate | 6 months | — |
| Occurrence of study related adverse events | 6 months | defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment |
Countries
China
Contacts
Primary ContactHUISHENG AI
Outcome results
None listed