acute lymphoblastic leukemia. Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
Intervention group: All patients are included in the only intervention arm of the study. Patients in the intervention arm will receive two doses of in-vitro expanded NK cells at the 6 and 12 days afte
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18 years old or more Patients with B-ALL or T-ALL who are MRD positive after receiving therapy.
Exclusion criteria
Exclusion criteria: Symptomatic coronary artery disease Karnofsky Performance Score < 60 Patients with uncontrolled bacterial, viral or fungal infection Acute graft versus host disease Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Grades 3-5 of Natural Killer cell infusion-related Adverse Events. Timepoint: Daily during the first seven days after the injection. Method of measurement: History, Physical exam, and lab test.;Relapse Incidence. Timepoint: one year after infusion. Method of measurement: Bone marrow aspiration and biopsy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of MRD negativity in patients after injection of natural killer cells. Timepoint: 1, 3, 6, 9 and 12 months post transplant. Method of measurement: Bone marrow aspiration and flowcytometry.;Incidence of acute graft versus host disease. Timepoint: Monthly for 4 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Barkhordar
Tehran University of Medical Sciences
Outcome results
None listed