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

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:
NCT01676558
First received: August 24, 2012
Last updated: November 13, 2012
Last verified: August 2012

August 24, 2012
November 13, 2012
June 2012
June 2016   (final data collection date for primary outcome measure)
overall response rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ 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 event [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: within 4 weeks since 1st dose of study drug and every 3 months once all study drugs are completed ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
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
Both
20 Years and older
No
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
Korea, Republic of
 
NCT01676558
DLBCL_131I-rituximab RIT
No
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