A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

November 13, 2012 updated by: Korea Cancer Center Hospital

A Phase II Study of 131I-rituximab for Elderly or Poor Performance Status Patients With Diffuse Large B Cell Lymphoma (DLBCL) or for Adult Patients With Relapsed or Refractory DLBCL

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status, refractoriness, and relapsed disease still remains. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

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 Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 139-706
        • Recruiting
        • Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
      • Seoul, Korea, Republic of
        • 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:
          • Byung Il Kim, M.D.
        • Sub-Investigator:
          • Chang Woon Choi, M.D.
        • Sub-Investigator:
          • Ilhan Im, 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 diffuse large B cell lymphoma Elderly (>65 years) or medically ineligible to standard cytotoxic chemotherapy due to poor performance status, or relapsed or refractory patients Eastern Cooperative Oncology Group performance status ≤ 2, age≥ 20 years Relapsed or refractory after autologous hematopoietic stem cell transplantation (auto-HSCT) in young patients with good performance status and indicated to high dose chemotherapy and auto-HSCT 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) Young patient with good performance status indicated to autologous hematopoietic stem cell transplantation irrespective of the failure of 1st line chemotherapy

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
Response duration
Time Frame: up to 5 years
up to 5 years
progression free survival
Time Frame: up to 5 years
up to 5 years
Number of Adverse event
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

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

June 1, 2012

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

August 31, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DLBCL_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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