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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Korea Cancer Center Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01676558
First Posted: August 31, 2012
Last Update Posted: November 14, 2012
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.
Information provided by:
Korea Cancer Center Hospital
August 24, 2012
August 31, 2012
November 14, 2012
June 2012
June 2016   (Final data collection date for primary outcome measure)
overall response rate [ Time Frame: up to 5 years ]
International Working Group Response criteria
overall response rate [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ]
Internationa Working Group Response criteria
Complete list of historical versions of study NCT01676558 on ClinicalTrials.gov Archive Site
  • 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 event [ Time Frame: up to 5 years ]
    grading the adverse events using CTCAE version 4.03
  • Response duration [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ]
  • progression free survival [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ]
  • Overall survival [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ]
  • Safety [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ]
    grading the adverse events using CTCAE version 4.03
Not Provided
Not Provided
 
A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Relapsed or Refractory Diffuse Large B Cell Lymphoma
Drug: 131I-rituximab
Experimental: 131I-rituximab
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Intervention: Drug: 131I-rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
June 2017
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01676558
DLBCL_131I-rituximab RIT
No
Not Provided
Not Provided
Not Provided
Korea Cancer Center Hospital
Not Provided
Not Provided
Korea Cancer Center Hospital
August 2012

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