The purpose of the study is to conduct a phase I study of adoptive immunotherapy with autologous, ex-vivo expanded cytokine-induced killer (CIK) cells to reduce the relapse rate in autologous stem cell transplant patients with high-risk hematologic malignancies.
Disease relapse remains the major cause of treatment failure in autologous stem cell transplantation for patients with high-risk disease. Relapse after autologous transplant is in part due to the persistence of residual cancer cells. Cellular immunotherapy using activated autologous effector cells to recognize and kill tumor targets in a minimal disease state after transplant is a strategy being explored to reduce relapse and improve survival. We hypothesize that cytokine-induced killer (CIK) cell-based immunotherapy can reduce the relapse rate after high-risk autologous stem cell transplantation by treating post-transplant minimal residual disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
22
Stanford University School of Medicine
Stanford, California, United States
To document the toxicities of infusion of autologous CIK cells
Time frame: Day 42 post autologous stem cell transplant
Measure freedom from progression (FFP)
Time frame: 1 and 2 years post-transplant
Measure event free survival
Time frame: 1 and 2 years post-transplant
Measure overall survival
Time frame: 1 and 2 years post-transplant
Measure disease response
Time frame: at day 40-60, day 90, day 180, and yearly
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100 mg/kg
1250 mg/m2
30 mg/m2
200 mg/m2