Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02497898
• Other study ID #: RNHL001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 29, 2015
• Last updated: July 12, 2015
• Start date: July 2015
• Est. completion date: July 2040

Study information

• Verified date: June 2015
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 2040
• Est. primary completion date: July 2038
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lactic Dehydrogenase (LDH)		1 month	No
Primary	Progression-Free-Survival (PFS)		1 month	No
Secondary	Overall Survival (OS)		1 month	No