About this trial
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.
First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
ECOG scores were 0 to 2
Disqualifiers
Presence of bone marrow or/and central nervous system lymphoma.
Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.
Combined with other malignancies.
Fever of non-disease-related origin within the last 5 days.
Trial design
Single group
Treatments tested in this trial
autologous NK cell
Combination productautologous NK cell
Treatment groups
Trial outcomes
Primary outcomes
ORR
Refer to the 2014 version of Lugano standard
Secondary outcomes
CR
Refer to the 2014 version of Lugano standard
PR
Refer to the 2014 version of Lugano standard
SD
Refer to the 2014 version of Lugano standard
PD
Refer to the 2014 version of Lugano standard
Sponsors and contacts
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Xiangyang No.1 People's Hospital
Lead sponsor
Qingdao Haier Biotechnology Co.,Ltd.
Collaborator
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