Combination of Rituximab and NK Immunotherapy for B Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2019-07-01

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.

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab and NK immunotherapy

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).

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

NK immunotherapy

Intervention Type BIOLOGICAL

Each time 10 billion cells, 4 times in all,i.v.

Rituximab

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).

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

Interventions

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Rituximab

Intervention Type DRUG

NK immunotherapy

Each time 10 billion cells, 4 times in all,i.v.

Intervention Type BIOLOGICAL

Other Intervention Names

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IDEC-C2B8 or Rituxan natural killer cell

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No