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

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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

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 5, 2012
Last Update Posted Date September 5, 2012
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
Overall response rate [ Time Frame: up to 5 years ]
International Working Group Response criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2012)
  • Response duration [ Time Frame: up to 5 years ]
  • Progression free survival [ Time Frame: up to 5 years ]
  • Overall survival [ Time Frame: up to 5 years ]
  • Number of Adverse Events [ Time Frame: up to 5 years ]
    grading the adverse events using CTCAE version 4.03
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma
Official Title  ICMJE A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory Marginal Zone B-cell Lymphoma
Intervention  ICMJE Drug: 131I-rituximab
Study Arms  ICMJE Experimental: 131I-rituximab
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Intervention: Drug: 131I-rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 4, 2012)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678404
Other Study ID Numbers  ICMJE MZL 131I-rituximab RIT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Korea Cancer Center Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hye Jin Kang, M.D. Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
PRS Account Korea Cancer Center Hospital
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP