B-cell Lymphoma Recurrent
Conditions
Keywords
B lymphoma, Rituximab, NK immunotherapy
Brief summary
The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to recurrent B lymphoma.
Detailed description
By enrolling patients with B lymphoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Rituximab and natural killer (NK) cells. The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).
Interventions
DRUGRituximab
BIOLOGICALNK immunotherapy
Each time 10 billion cells, 4 times in all,i.v.
Sponsors
Shenzhen Hank Bioengineering Institute
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence * Body tumor 1-6, the maximum tumor length \< 5 cm * KPS ≥ 70, lifespan \> 6 months * Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L
Exclusion criteria
* Patients with cardiac pacemaker * Patients with brain metastasis * Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief degree evaluated by the RECIST | 3 months | It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS) | 1 year |
| Overall survival (OS) | 3 years |
Countries
China
Outcome results
None listed