Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma
July 12, 2015 updated by: The First People's Hospital of Changzhou
A Randomized Controlled Clinical Trial of Cytokine-induced Killer (CIK) Cells Treatment in Patients With Refractory Non-Hodgkin Lymphoma
The purpose of this study is to study the safety and efficacy of chemotherapy usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Autologous cytokine-induced killer (CIK) cells transfusion(>2*10^9 cells count) within 2 weeks after regular chemotherapy every 3 months.
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed as non-Hodgkin lymphoma with negative effect of regular chemotherapy, and need further therapy
Exclusion Criteria:
- patients refuse the therapy or have no tolerance for the therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: regular chemotherapy
Patients after chemotherapy are just followed up.
|
|
|
Experimental: CIK regimen
Patients after chemotherapy will receive at least 3 cycles of Cytokine-induced killer cells (CIK) treatment every 3 months.
|
Cytokine-induced killer (CIK) cells are able to eradicate lymphomas and other malignancies.
CIK cells are generated by incubation of peripheral blood lymphocytes with an anti-cluster of differentiation 3 (anti-CD3) monoclonal antibody, interleukin-2 (IL-2), interleukin-1 (IL-1) and interferon-gamma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Progression-Free-Survival (PFS)
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall Survival (OS)
Time Frame: 1 month
|
1 month
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Lactic Dehydrogenase (LDH)
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Anticipated)
July 1, 2038
Study Completion (Anticipated)
July 1, 2040
Study Registration Dates
First Submitted
June 29, 2015
First Submitted That Met QC Criteria
July 12, 2015
First Posted (Estimate)
July 15, 2015
Study Record Updates
Last Update Posted (Estimate)
July 15, 2015
Last Update Submitted That Met QC Criteria
July 12, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNHL001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.