Relapsed or Refractory Diffuse Large B Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of 131I-rituximab for Elderly or Poor Performance Status Patients With Diffuse Large B Cell Lymphoma (DLBCL) or for Adult Patients With Relapsed or Refractory DLBCL
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.
| Status | Recruiting |
| Enrollment | 24 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences | Seoul | |
| Korea, Republic of | Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Korea Cancer Center Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall response rate | International Working Group Response criteria | up to 5 years | No |
| Secondary | Response duration | up to 5 years | No | |
| Secondary | progression free survival | up to 5 years | No | |
| Secondary | Overall survival | up to 5 years | No | |
| Secondary | Number of Adverse event | grading the adverse events using CTCAE version 4.03 | up to 5 years | Yes |