131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma

Korea Cancer Center Hospital

Status and phase

Unknown

Phase 2

Conditions

Relapsed or Refractory Marginal Zone B-cell Lymphoma

Treatments

Drug: 131I-rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT01678404

MZL 131I-rituximab RIT

Details and patient eligibility

About

Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with variable differentiation status, which is distributed to a variety of organs.

A high response rate and long term survival is possible through surgery or radiation therapy alone in the case of limited disease. However frequent relapse and progression is observed despite of long term survival. The treatment after relapse has not been established yet.

So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with MZL.

Enrollment

28 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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 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)