Combination of Rituximab and NK Immunotherapy for B Lymphoma

Study Overview
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Brief Summary
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The aim of this study is the safety and efficacy of Rituximab plus NK immunotherapy to recurrent B lymphoma.

Detailed Description
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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).

Conditions
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B-cell Lymphoma Recurrent

Intervention / Treatment
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* Drug: Rituximab
* Biological: NK immunotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab and NK immunotherapy<br>In this group, the patients will receive regular Rituximab treatment accompanied with multiple NK immunotherapy. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Rituximab<br> <br> * Other names: IDEC-C2B8 or Rituxan;Biological: NK immunotherapy<br>* Each time 10 billion cells, 4 times in all,i.v.<br>* Other names: natural killer cell;|
| Active Comparator: Rituximab<br>In this group, the patients will receive regular Rituximab to decrease tumor burden. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell). | Drug: Rituximab<br> <br> * Other names: IDEC-C2B8 or Rituxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree evaluated by the RECIST | It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival (PFS) |  | 1 year | 
| Overall survival (OS) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B lymphoma, Rituximab, NK immunotherapy