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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Korea Cancer Center Hospital
Sponsor:
Information provided by:
Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:
NCT01678404
First received: September 4, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Korea Cancer Center Hospital:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    International Working Group Response criteria


Secondary Outcome Measures:
  • Response duration [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Number of Adverse Events [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    grading the adverse events using CTCAE version 4.03


Estimated Enrollment: 28
Study Start Date: October 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 131I-rituximab
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Drug: 131I-rituximab

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678404

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

No publications provided

ClinicalTrials.gov Identifier: NCT01678404     History of Changes
Other Study ID Numbers: MZL 131I-rituximab RIT
Study First Received: September 4, 2012
Last Updated: September 4, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
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
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014