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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678404
Recruitment Status : Unknown
Verified August 2012 by Korea Cancer Center Hospital.
Recruitment status was:  Recruiting
First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by:
Korea Cancer Center Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Relapsed or Refractory Marginal Zone B-cell Lymphoma Drug: 131I-rituximab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma
Study Start Date : October 2011
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 131I-rituximab
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
 Drug: 131I-rituximab


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 5 years ]
    International Working Group Response criteria


Secondary Outcome Measures :
  1. Response duration [ Time Frame: up to 5 years ]
  2. Progression free survival [ Time Frame: up to 5 years ]
  3. Overall survival [ Time Frame: up to 5 years ]
  4. Number of Adverse Events [ Time Frame: up to 5 years ]
    grading the adverse events using CTCAE version 4.03


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678404


Contacts
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Contact: Hye Jin kang, M.D. +82-2-970-1289 mdhyejin@gmail.com
Contact: Dong-Yeop Shin, M.D. +82-2-970-1246 baramg@hanmail.net

Locations
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Korea, Republic of
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences Recruiting
Seoul, Korea, Republic of, 139-706
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.         
Sponsors and Collaborators
Korea Cancer Center Hospital
Investigators
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Principal Investigator: Hye Jin Kang, M.D. Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
More Information
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ClinicalTrials.gov Identifier: NCT01678404    
Other Study ID Numbers: MZL 131I-rituximab RIT
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents