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Trial Title:
Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma
NCT ID:
NCT05909098
Condition:
NK Cell
B-cell Lymphoma Recurrent
B-cell Lymphoma Refractory
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
autologous NK cell
Description:
autologous NK cell
Arm group label:
NK cell
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
2. 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.
3. First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
4. ECOG scores were 0 to 2
5. Presence of at least one CT measurable lesion locus with a maximum transverse
diameter of ≥1.5 cm before inclusion in the study.
6. For women of childbearing potential, a negative pregnancy test must be confirmed
before inclusion in the study and no intention to have children within 2 years.
7. For men of childbearing potential, inform and require the use of an effective
barrier contraceptive method.
8. Volunteer to participate in the trial and sign the informed consent form.
Exclusion Criteria:
1. Presence of bone marrow or/and central nervous system lymphoma.
2. Patients with less than 5% peripheral blood NK cell percentage and pre-culture
failure.
3. Combined with other malignancies.
4. Fever of non-disease-related origin within the last 5 days.
5. Presence of uncontrollable bacterial, fungal, viral or other infections.
6. Patients with HIV, TP positive
7. Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction
are present.
8. Presence of other serious diseases that conflict with this protocol, such as
autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet
dysfunction syndrome, etc.
9. Received any form of organ transplantation, including allogeneic stem cell
transplantation.
10. Presence of a serious psychiatric disorder.
11. Inability to communicate normally and incapacitation make it difficult to assess the
safety and effectiveness of treatment.
12. Pregnant or lactating women.
13. The researchers deemed unsuitable for participation in this study. -
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
EC of Xiangyang No.1 People's Hospital Hubei University of Medicine
Address:
City:
Hubei
Zip:
441000
Country:
China
Contact:
Last name:
Jiwu He
Phone:
+86 07103122615
Email:
xzyxhgx@163.com
Start date:
July 1, 2023
Completion date:
November 30, 2028
Lead sponsor:
Agency:
Xiangyang No.1 People's Hospital
Agency class:
Other
Collaborator:
Agency:
Qingdao Haier Biotechnology Co.,Ltd.
Agency class:
Other
Source:
Xiangyang No.1 People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05909098
