Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients

NCT00846157 | Unknown Phase 3

• 1 other identifier: NKMGI 4-06
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective:

• To compare the event free survival for 3years of R-CHOP plus Biocell Natural Killer Cell to R-CHOP therapy with DLBCL patients.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

natural killer cell; DLBCL (Diffuse Large B Cell Lymphoma)

Outcome Measures

Primary Outcomes (1)

• Event Free survival

  3 years

Secondary Outcomes (1)

• Progression free survival

  3 years

Study Arms (2)

control

NO INTERVENTION

Rituximab 375mg/m2 IV administered on day 1. Cyclophosphamide 750mg/m2 IV for 2hours,Adriamycin 50mg/m2 ,Vincristine 1.4mg/m2 IV respectively. Prednisone 60mg P.O. per day for 5 days.

Active

ACTIVE COMPARATOR

R-CHOP plus Natural Killer Cell therapy

Biological: NKM injection

Interventions

NKM injection BIOLOGICAL

NKCell about 100mg IV for 6times in each chemotherapy period.

Also known as: NKCell

Active

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of the age between 20 and 70
• The patients who have measurable lesion using radiograph and have not received chemotherapy and radiation therapy after confirming DCBCL.
• The patients with Ann arbor Ⅰ, Ⅱ, Ⅲ, Ⅳ
• The patients who have not received NK / T-Cell lymphocyte therapy.
• The patients who are expected to survive for at least 3 months.
• The patients who or whose representative voluntary have written informed consent before performance of any study-related procedure.
• Women of child bearing potential must have a negative pregnancy test within 7 days prior to study registration and agree to use adequate birth control during study treatment.
• The patients with ADL classification (ECOG) scale 0, 1, 2
• Patients who satisfy following hematologic criteria
• WBC ≥ 3,000 / ㎕
• platelet count ≥ 75,000 / ㎕
• serum total bilirubin ≤ two times of upper limit of normal values of each laboratory
• serum creatinine ≤ two times of upper limit of normal values of each laboratory
• lymphoma patients who satisfy the following criteria
• good renal function (GFR\> 50)

You may not qualify if:

• The minors under 20 years of age (In accordance with Civil Code)
• The patients diagnosed with other types of lymphoma
• The patients who have central nervous system or meningeal involvement by lymphoma.
• The patients who have contraindication of chemotherapy regimen
• The patients with another active severe disease.
• The patients who have history of cancer within 5 years
• Uncontrolled hypertension patients
• The patients who have hypersensitivity to Erythropoietin.
• The patients who have the following diseases or the experience to have following disease within 3 months.
• Myocardial infarction
• Unstable coronary disease
• Uncontrolled cardiac insufficiency.
• Venous thrombosis
• Pulmonary embolism
• The patients who have experience to be treated with the pharmaceutical for clinical trials.

Sponsors & Collaborators

• NKBio Co.Ltd.: lead

Study Sites (1)

The Catholic University of korea

Banpo-dong, Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Dendritic Cell Sarcoma, Interdigitating

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Histiocytic Disorders, Malignant; Histiocytosis

Study Officials

• Seok-Goo Cho, MD,PhD

  Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 15, 2009
• First Posted: February 18, 2009
• Study Start: September 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2014
• Last Updated: June 28, 2011

Record last verified: 2009-02

Locations

KR (1)