NCT01678417
Unknown
Phase 2
A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
Korea Cancer Center Hospital1 site in 1 country29 target enrollmentStarted: June 2012Last updated:
Interventions131I-rituximab
Drugs131I-rituximab
Overview
- Phase
- Phase 2
- Sponsor
- Korea Cancer Center Hospital
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Overall response rate
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
131I-rituximab
Experimental
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Intervention: 131I-rituximab (Drug)
Outcomes
Primary Outcomes
Overall response rate
Time Frame: up to 5 years
Secondary Outcomes
- progression free survival(up to 5 years)
- Response duration(up to 5 years)
- Overall survival(up to 5 years)
- Number of Adverse Events(up to 5 years)
Investigators
Study Sites (1)
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