atural Killer cell in Acute Lymphoblastic Leukemia
Phase 1
Recruiting
- Conditions
- acute lymphoblastic leukemia.Acute lymphoblastic leukemia [ALL]C91.0
- Registration Number
- IRCT20140818018842N38
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Age 18 years old or more
Patients with B-ALL or T-ALL who are MRD positive after receiving therapy.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber 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 Outcome Measures
Name Time Method 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.