Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma
Conditions
Brief summary
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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Response duration | up to 5 years |
| Overall survival | up to 5 years |
| Number of Adverse Events | up to 5 years |
| progression free survival | up to 5 years |
Countries
South Korea
Contacts
Primary ContactHye Jin Kang, M.D.
Backup ContactDong-Yeop Shin, M.D.
Outcome results
None listed