Back to resultsA Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Primary Purpose
Relapsed or Refractory Diffuse Large B Cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
131I-rituximab
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Diffuse Large B Cell Lymphoma focused on measuring diffuse large B cell lymphoma, radioimmunotherapy, 131I-rituximab
Eligibility 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
Sites / Locations
- Korea Cancer Center Hospital, Korea Institute of Radiological and Medical SciencesRecruiting
- Korea Cancer Center Hospital, Korea Institute of Radiological and Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
131I-rituximab
Arm Description
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Outcomes
Primary Outcome Measures
overall response rate
International Working Group Response criteria
Secondary Outcome Measures
Response duration
progression free survival
Overall survival
Number of Adverse event
grading the adverse events using CTCAE version 4.03
Full Information
NCT ID
NCT01676558
First Posted
August 24, 2012
Last Updated
November 13, 2012
Sponsor
Korea Cancer Center Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01676558
Brief Title
A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Korea Cancer Center Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Diffuse Large B Cell Lymphoma
Keywords
diffuse large B cell lymphoma, radioimmunotherapy, 131I-rituximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
131I-rituximab
Arm Type
Experimental
Arm Description
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
Intervention Type
Drug
Intervention Name(s)
131I-rituximab
Primary Outcome Measure Information:
Title
overall response rate
Description
International Working Group Response criteria
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Response duration
Time Frame
up to 5 years
Title
progression free survival
Time Frame
up to 5 years
Title
Overall survival
Time Frame
up to 5 years
Title
Number of Adverse event
Description
grading the adverse events using CTCAE version 4.03
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hye Jin Kang, M.D.
Phone
+82-2-970-1289
Email
mdhyejin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Yeop Shin, M.D.
Phone
+82-2-970-1246
Email
baramg@hanmail.net
Facility Information:
Facility Name
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
City
Seoul
ZIP/Postal Code
139-706
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Jin Kang, M.D.
First Name & Middle Initial & Last Name & Degree
Dong-Yeop Shin, M.D.
First Name & Middle Initial & Last Name & Degree
Hye Jin Kang, M.D.
First Name & Middle Initial & Last Name & Degree
Dong-Yeop Shin, M.D.
First Name & Middle Initial & Last Name & Degree
Sung Hyun Yang, M.D.
First Name & Middle Initial & Last Name & Degree
Im Il Na, M.D.
First Name & Middle Initial & Last Name & Degree
Hyo-Rak Lee, M.D.
First Name & Middle Initial & Last Name & Degree
Sang Moo Lim, M.D.
First Name & Middle Initial & Last Name & Degree
Chang Woon Choi, M.D.
First Name & Middle Initial & Last Name & Degree
Byung Il Kim, M.D.
First Name & Middle Initial & Last Name & Degree
Ilhan Im, M.D.
First Name & Middle Initial & Last Name & Degree
Seung Sook Lee, M.D.
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)
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