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A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma

Phase 2
20 Years
Open (Enrolling)
Relapsed or Refractory Marginal Zone B-cell Lymphoma

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Trial Information

A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma

Inclusion Criteria:

- Histologically confirmed marginal zone B-cell lymphoma

- relapsed or refractory patients after treatment including chemotherapy, radiation
therapy, and surgery

- 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

- 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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

International Working Group Response criteria

Outcome Time Frame:

up to 5 years

Safety Issue:


Principal Investigator

Hye Jin Kang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences


Korea: Food and Drug Administration

Study ID:

MZL 131I-rituximab RIT



Start Date:

October 2011

Completion Date:

September 2016

Related Keywords:

  • Relapsed or Refractory Marginal Zone B-cell Lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone