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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 event [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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: 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
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.         
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences Recruiting
Seoul, Korea, Republic of, 139-706
Sponsors and Collaborators
Korea Cancer Center Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01676558     History of Changes
Other Study ID Numbers: DLBCL_131I-rituximab RIT
Study First Received: August 24, 2012
Last Updated: November 13, 2012
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 22, 2014