NCT02497898

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_2

Timeline
171mo left

Started Jul 2015

Longer than P75 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jul 2015Jul 2040

First Submitted

Initial submission to the registry

June 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
23 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2038

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2040

Last Updated

July 15, 2015

Status Verified

June 1, 2015

Enrollment Period

23 years

First QC Date

June 29, 2015

Last Update Submit

July 12, 2015

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (1)

  • Progression-Free-Survival (PFS)

    1 month

Secondary Outcomes (1)

  • Overall Survival (OS)

    1 month

Other Outcomes (1)

  • Lactic Dehydrogenase (LDH)

    1 month

Study Arms (2)

regular chemotherapy

NO INTERVENTION

Patients after chemotherapy are just followed up.

CIK regimen

EXPERIMENTAL

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)

Interventions

Cytokine-induced killer cells (CIK)BIOLOGICAL

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.

CIK regimen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed as non-Hodgkin lymphoma with negative effect of regular chemotherapy, and need further therapy

You may not qualify if:

  • patients refuse the therapy or have no tolerance for the therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 15, 2015

Study Start

July 1, 2015

Primary Completion (Estimated)

July 1, 2038

Study Completion (Estimated)

July 1, 2040

Last Updated

July 15, 2015

Record last verified: 2015-06