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Primary objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKM injection | Biological | NKCell about 100mg IV for 6times in each chemotherapy period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event Free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 3 years |
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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 â… , â…¡, â…¢, â…£
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
lymphoma patients who satisfy the following criteria
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Seok-Goo Cho, MD,PhD | Catholic Hematopoietic Stem Cell Transplantation Center in The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of korea | Banpo-dong | Seoul | 137-701 | South Korea |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |