Back to results131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma
Primary Purpose
Relapsed or Refractory Follicular Lymphoma or Mantle 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 Follicular Lymphoma or Mantle Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed follicular lymphoma or mantle cell lymphoma
- relapsed or refractory patients
- Eastern Cooperative Oncology Group performance status ≤ 2
- age≥ 20 years
- 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)
Sites / Locations
- 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
Secondary Outcome Measures
Response duration
Overall survival
Number of Adverse Events
progression free survival
Full Information
NCT ID
NCT01678417
First Posted
August 30, 2012
Last Updated
September 4, 2012
Sponsor
Korea Cancer Center Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01678417
Brief Title
131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma
Official Title
A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
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 2017 (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
Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has relatively good prognosis, continual treatment is needed due to frequent relapse. FL with histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma. Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with FL or MCL
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (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
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Response duration
Time Frame
up to 5 years
Title
Overall survival
Time Frame
up to 5 years
Title
Number of Adverse Events
Time Frame
up to 5 years
Title
progression free survival
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 follicular lymphoma or mantle cell lymphoma
relapsed or refractory patients
Eastern Cooperative Oncology Group performance status ≤ 2
age≥ 20 years
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Jin Kang, M.D.
Organizational Affiliation
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Official's Role
Principal Investigator
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 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
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 Lim, M.D.
First Name & Middle Initial & Last Name & Degree
Seung-Sook Lee, M.D.
12. IPD Sharing Statement
Learn more about this trial
131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma
We'll reach out to this number within 24 hrs