Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has relatively good prognosis, continual treatment is needed due to frequent relapse. FL with histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma. Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with FL or MCL
| Status | Recruiting |
| Enrollment | 29 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Histologically confirmed follicular lymphoma or mantle cell lymphoma - relapsed or refractory patients - Eastern Cooperative Oncology Group performance status = 2 - age= 20 years - 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) |
Endpoint Classification: 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Korea Cancer Center Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate | up to 5 years | No | |
| Secondary | Response duration | up to 5 years | No | |
| Secondary | Overall survival | up to 5 years | No | |
| Secondary | Number of Adverse Events | up to 5 years | Yes | |
| Secondary | progression free survival | up to 5 years | No |