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

NKBio

Status and phase: Unknown; Phase 3

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Biological: NKM injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00846157

NKMGI 4-06

Details and patient eligibility

About

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.

Enrollment: 276 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women of the age between 20 and 70

2. The patients who have measurable lesion using radiograph and have not received chemotherapy and radiation therapy after confirming DCBCL.

3. The patients with Ann arbor Ⅰ, Ⅱ, Ⅲ, Ⅳ

4. The patients who have not received NK / T-Cell lymphocyte therapy.

5. The patients who are expected to survive for at least 3 months.

6. The patients who or whose representative voluntary have written informed consent before performance of any study-related procedure.

7. 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.

8. The patients with ADL classification (ECOG) scale 0, 1, 2

9. 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

10. 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)

11. The patients with negative HIV surface antigen

12. The patients with negative HBV

13. The patients with negative HCV

14. The patients who have not received immunotherapy.

15. The patients who have not experienced tuberculosis infection within recent 6 months.

Exclusion criteria

1. The minors under 20 years of age (In accordance with Civil Code)

2. The patients diagnosed with other types of lymphoma

3. The patients who have central nervous system or meningeal involvement by lymphoma.

4. The patients who have contraindication of chemotherapy regimen

5. The patients with another active severe disease.

6. The patients who have history of cancer within 5 years

7. Uncontrolled hypertension patients

8. The patients who have hypersensitivity to Erythropoietin.

9. 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

10. The patients who have experience to be treated with the pharmaceutical for clinical trials.

11. Pregnant and lactating women or women of childbearing age not using adequate contraceptive method.

12. The patients with clinically serious bacterial, viral or fungal infection

13. 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)

14. Patients with autoimmune diseases

15. The patients who underwent visceral resection related with Lymphoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

control

No Intervention group

Description:

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 group

Description:

R-CHOP plus Natural Killer Cell therapy

Treatment:

Biological: NKM injection