search
Back to results

Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cytokine-induced killer cells (CIK)
Sponsored by
The First People's Hospital of Changzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    regular chemotherapy

    CIK regimen

    Arm Description

    Patients after chemotherapy are just followed up.

    Patients after chemotherapy will receive at least 3 cycles of Cytokine-induced killer cells (CIK) treatment every 3 months.

    Outcomes

    Primary Outcome Measures

    Progression-Free-Survival (PFS)

    Secondary Outcome Measures

    Overall Survival (OS)

    Full Information

    First Posted
    June 29, 2015
    Last Updated
    July 12, 2015
    Sponsor
    The First People's Hospital of Changzhou
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02497898
    Brief Title
    Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma
    Official Title
    A Randomized Controlled Clinical Trial of Cytokine-induced Killer (CIK) Cells Treatment in Patients With Refractory Non-Hodgkin Lymphoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    July 2038 (Anticipated)
    Study Completion Date
    July 2040 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First People's Hospital of Changzhou

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Autologous cytokine-induced killer (CIK) cells transfusion(>2*10^9 cells count) within 2 weeks after regular chemotherapy every 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Non-Hodgkin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    regular chemotherapy
    Arm Type
    No Intervention
    Arm Description
    Patients after chemotherapy are just followed up.
    Arm Title
    CIK regimen
    Arm Type
    Experimental
    Arm Description
    Patients after chemotherapy will receive at least 3 cycles of Cytokine-induced killer cells (CIK) treatment every 3 months.
    Intervention Type
    Biological
    Intervention Name(s)
    Cytokine-induced killer cells (CIK)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Progression-Free-Survival (PFS)
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Overall Survival (OS)
    Time Frame
    1 month
    Other Pre-specified Outcome Measures:
    Title
    Lactic Dehydrogenase (LDH)
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma

    We'll reach out to this number within 24 hrs