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A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma

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Trial Information

A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Principal Investigator

Hye Jin Kang, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Korea: Food and Drug Administration

Study ID:

FL or MCL 131I-rituximab RIT

NCT ID:

NCT01678417

Start Date:

June 2012

Completion Date:

June 2017

Related Keywords:

  • Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell

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