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Combination of Rituximab and NK Immunotherapy for B Lymphoma

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ClinicalTrials.gov Identifier: NCT02843061
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Collaborator:
Shenzhen Hank Bioengineering Institute
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Recurrent Drug: Rituximab Biological: NK immunotherapy Phase 1 Phase 2

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: 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).
Drug: Rituximab
Other Name: IDEC-C2B8 or Rituxan

Biological: NK immunotherapy
Each time 10 billion cells, 4 times in all,i.v.
Other Name: natural killer cell

Active Comparator: 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).
Drug: Rituximab
Other Name: IDEC-C2B8 or Rituxan




Primary Outcome Measures :
  1. Relief degree evaluated by the RECIST [ Time Frame: 3 months ]
    It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)


Secondary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: 1 year ]
  2. Overall survival (OS) [ Time Frame: 3 years ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843061


Contacts
Contact: Jibing Chen, MD, PhD +86-13068872049 jibingchen398@163.com

Locations
China, Guangdong
Cancer Institute in Fuda cancer hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Jibing Chen, MD, PhD    +86-18903068207    jibingchen398@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Shenzhen Hank Bioengineering Institute
Investigators
Principal Investigator: Jibing Chen, MD, PhD Fuda Cancer Hospital, Guangzhou

Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02843061     History of Changes
Other Study ID Numbers: NK-Rituximab
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016

Keywords provided by Fuda Cancer Hospital, Guangzhou:
B lymphoma
Rituximab
NK immunotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents