Acute myeloid leukemia. Acute myeloblastic leukaemia
Conditions
Sponsors
Shahid Beheshti University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
12 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients with acute myeloid leukemia (other than M3) confirmed by peripheral blood and bone marrow morphology, and flow cytometry and molecular assessments History of transplantation with compatible allogeneic hematopoietic stem cells Kanofsky index above 70% Expected survival of more than six months Absence of other confirmed malignancies Entering the second complete remission phase (recovery of patients after the first recurrence) High risk-patients with negative or positive minimal residual disease
Exclusion criteria
Exclusion criteria: Patients with acute myeloid leukemia-M3 Central nervous system involvement with leukemic cells in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who show adverse effects during or after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: The patient's statements and the medical team's examinations during the patient's regular visits to the bone marrow transplantation clinic for follow-up.;Overall survival in patients after NK cell therapy. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.;Response to treatment based on criteria defined by the International Multiple Myeloma Working Group. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient examination in bone marrow transplantation clinic for follow-up and based on criteria defined by the International Multiple Myeloma Working Group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of "Event Free Survival" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.;Evaluation of "Progression free survival" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.;Evaluation of "non-relapse mortality" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.;Evaluation of "Overall survival" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients.;Evaluation of "graft versus host disease" in a six month period. Timepoint: From the first dose of NK cells infusion until six months after its last dose. Method of measurement: Regular patient visits to bone marrow transplantation clinic for follow-up and regular telephone monitoring of patients. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElham Roshandel
Shahid Beheshti University of Medical Sciences
Outcome results
None listed