Biocell Natural Killer Mixture in Diffuse Large B Cell Lymphoma (DLBCL) Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Diffuse Large B-cell Lymphoma	Biological: NKM injection	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	R-CHOP Therapy Compared With R-CHOP Plus Biocell Natural Killer Mixture in Patients With DLBCL (Diffuse Large B Cell Lymphoma);A Randomized, Open-label,Multi-center Trail

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

U.S. FDA Resources

Further study details as provided by NKBio Co.Ltd.:

Primary Outcome Measures:

Event Free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	276
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: control 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 Comparator: Active R-CHOP plus Natural Killer Cell therapy	Biological: NKM injection NKCell about 100mg IV for 6times in each chemotherapy period. Other Name: NKCell

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)
- good hepatic function (total bilirubin level ≤ three times of upper limit of normal values of each test laboratory transaminases ≤ 5 times of the upper limit of normal value of each testing laboratory)
The patients with negative HIV surface antigen
The patients with negative HBV
The patients with negative HCV
The patients who have not received immunotherapy.
The patients who have not experienced tuberculosis infection within recent 6 months.

Exclusion Criteria:

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.
Pregnant and lactating women or women of childbearing age not using adequate contraceptive method.
The patients with clinically serious bacterial, viral or fungal infection
The patients of the test group who have the problem in NK cell cultures (Investigator will decide on this criteria with basis generated during NK cell culture)
Patients with autoimmune diseases
The patients who underwent visceral resection related with Lymphoma.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846157

Locations

Korea, Republic of
The Catholic University of korea
Banpo-Dong 505, Seoul, Korea, Republic of, 137-701

Sponsors and Collaborators

NKBio Co.Ltd.

Investigators

Principal Investigator:

Seok-Goo Cho, MD,PhD

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

More Information

No publications provided

Responsible Party:	Lee,Jae-Kyu, Bio Bisiness Headquater/Assistant Manager in Cell Manufacture Team
ClinicalTrials.gov Identifier:	NCT00846157 History of Changes
Other Study ID Numbers:	NKMGI 4-06
Study First Received:	February 15, 2009
Last Updated:	June 26, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by NKBio Co.Ltd.:

natural killer cell
DLBCL (Diffuse Large B Cell Lymphoma)

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms

Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on May 23, 2013

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