Relapsed or Refractory Diffuse Large B Cell Lymphoma
Conditions
Keywords
diffuse large B cell lymphoma, radioimmunotherapy, 131I-rituximab
Brief summary
Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status, refractoriness, and relapsed disease still remains. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.
Interventions
DRUG131I-rituximab
Sponsors
Korea Cancer Center Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed diffuse large B cell lymphoma Elderly (\>65 years) or medically ineligible to standard cytotoxic chemotherapy due to poor performance status, or relapsed or refractory patients Eastern Cooperative Oncology Group performance status ≤ 2, age≥ 20 years Relapsed or refractory after autologous hematopoietic stem cell transplantation (auto-HSCT) in young patients with good performance status and indicated to high dose chemotherapy and auto-HSCT More than one measurable lesion * More than 2cm sized lesion in conventional CT scan, * More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min) Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit) Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕) patient who agree the purpose and intention of this clinical trial
Exclusion criteria
* recent (\<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded) * hemodynamically unstable due to the recent (\<12 months) history of severe heart disease such as myocardial infarction * acute complications of severe lung or metabolic disease * Combined severe neurological or psychiatric disease Unrecovered from infection or other medical disease Recent (\<30 days) history of enrollment of other clinical trial Pregnant or breast-feeding woman women of childbearing potential and men not employing adequate contraception at least for 1 year Previous history drug allergy to the content of 131I-rituximab Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled) Young patient with good performance status indicated to autologous hematopoietic stem cell transplantation irrespective of the failure of 1st line chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | up to 5 years | International Working Group Response criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response duration | up to 5 years | — |
| progression free survival | up to 5 years | — |
| Overall survival | up to 5 years | — |
| Number of Adverse event | up to 5 years | grading the adverse events using CTCAE version 4.03 |
Countries
South Korea
Contacts
Primary ContactHye Jin Kang, M.D.
Backup ContactDong-Yeop Shin, M.D.
Outcome results
None listed