Back to resultsCombination of Rituximab and NK Immunotherapy for B Lymphoma
Primary Purpose
B-cell Lymphoma Recurrent
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Rituximab
NK immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Lymphoma Recurrent focused on measuring B lymphoma, Rituximab, NK immunotherapy
Eligibility 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
Sites / Locations
- Cancer Institute in Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Rituximab and NK immunotherapy
Rituximab
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Relief degree evaluated by the RECIST
It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary Outcome Measures
Progress free survival (PFS)
Overall survival (OS)
Full Information
NCT ID
NCT02843061
First Posted
July 21, 2016
Last Updated
September 10, 2019
Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
1. Study Identification
Unique Protocol Identification Number
NCT02843061
Brief Title
Combination of Rituximab and NK Immunotherapy for B Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
Collaborators
Shenzhen Hank Bioengineering Institute
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphoma Recurrent
Keywords
B lymphoma, Rituximab, NK immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab and NK immunotherapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
IDEC-C2B8 or Rituxan
Intervention Type
Biological
Intervention Name(s)
NK immunotherapy
Other Intervention Name(s)
natural killer cell
Intervention Description
Each time 10 billion cells, 4 times in all,i.v.
Primary Outcome Measure Information:
Title
Relief degree evaluated by the RECIST
Description
It will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progress free survival (PFS)
Time Frame
1 year
Title
Overall survival (OS)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jibing Chen, MD, PhD
Organizational Affiliation
Fuda Cancer Hospital, Guangzhou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China
12. IPD Sharing Statement
Learn more about this trial
Combination of Rituximab and NK Immunotherapy for B Lymphoma
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