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

September 4, 2012 updated by: Korea Cancer Center Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 139-706
        • Recruiting
        • Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
        • Contact:
          • Hye Jin Kang, M.D.
        • Contact:
          • Dong-Yeop Shin, M.D.
        • Principal Investigator:
          • Hye Jin Kang, M.D.
        • Sub-Investigator:
          • Sung Hyun Yang, M.D.
        • Sub-Investigator:
          • Im Il Na, M.D.
        • Sub-Investigator:
          • Hyo-Rak Lee, M.D.
        • Sub-Investigator:
          • Dong-Yeop Shin, M.D.
        • Sub-Investigator:
          • Sang Moo Lim, M.D.
        • Sub-Investigator:
          • Change Woon Choi, M.D.
        • Sub-Investigator:
          • Byung Il Kim, M.D.
        • Sub-Investigator:
          • Ilhan Lim, M.D.
        • Sub-Investigator:
          • Seung-Sook Lee, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 131I-rituximab
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Drug: 131I-rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: up to 5 years
International Working Group Response criteria
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 5 years
up to 5 years
Progression free survival
Time Frame: up to 5 years
up to 5 years
Response duration
Time Frame: up to 5 years
up to 5 years
Number of Adverse Events
Time Frame: up to 5 years
grading the adverse events using CTCAE version 4.03
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Cancer Center Hospital

Investigators

  • Principal Investigator: Hye Jin Kang, M.D., Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 4, 2012

First Posted (Estimate)

September 5, 2012

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 4, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MZL 131I-rituximab RIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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