Clinical trial · Interventional
131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma
A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 131I-rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 131I-rituximab
- description
- 131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
- interventionNames
- Drug: 131I-rituximab
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- up to 5 years
Secondary outcomes (4)
- measure
- Response duration
- timeFrame
- up to 5 years
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available