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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
  Purpose
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.

Condition Intervention Phase
Relapsed or Refractory Diffuse Large B Cell Lymphoma Drug: 131I-rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

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 ]
    International Working Group Response criteria


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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

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
  Contacts and Locations
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): NCT01676558


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
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences Recruiting
Seoul, Korea, Republic of
Contact: Hye Jin Kang, M.D.         
Contact: Dong-Yeop Shin, M.D.         
Principal Investigator: Hye Jin Kang, M.D.         
Sub-Investigator: Dong-Yeop Shin, 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: Sang Moo Lim, M.D.         
Sub-Investigator: Chang Woon Choi, M.D.         
Sub-Investigator: Byung Il Kim, M.D.         
Sub-Investigator: Ilhan Im, M.D.         
Sub-Investigator: Seung Sook Lee, M.D.         
Sponsors and Collaborators
Korea Cancer Center Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01676558     History of Changes
Other Study ID Numbers: DLBCL_131I-rituximab RIT
First Submitted: August 24, 2012
First Posted: August 31, 2012
Last Update Posted: November 14, 2012
Last Verified: August 2012

Keywords provided by Korea Cancer Center Hospital:
diffuse large B cell lymphoma
radioimmunotherapy
131I-rituximab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents