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Status:

UNKNOWN

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

Lead Sponsor:

NKBio Co.Ltd.

Conditions:

Diffuse Large B-cell Lymphoma

Eligibility:

All Genders

20-70 years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2014

Estimated Enrollment :

276 Patients enrolled

Trial Details

Trial ID

NCT00846157

Start Date

September 1 2007

End Date

September 1 2014

Last Update

June 28 2011

Active Locations (1)

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1

The Catholic University of korea

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