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.
Biological: Cytokine-induced killer cells (CIK)
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.

Sponsor

The First People's Hospital of Changzhou

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.

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