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Not yet recruiting NCT02497898

Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma

Phase II Interventional Lymphoma, Non-Hodgkin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cytokine-induced killer cells (CIK).
Who it may be relevant to
Registry conditions: Lymphoma, Non-Hodgkin. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized Controlled Clinical Trial of Cytokine-induced Killer (CIK) Cells Treatment in Patients With Refractory Non-Hodgkin Lymphoma

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Progression-Free-Survival (PFS) [Time frame: 1 month]
Secondary outcome measures (1)
  • Overall Survival (OS) [Time frame: 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT02497898 · RNHL001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗