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Trial Title:
131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma
NCT ID:
NCT01678417
Condition:
Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Mantle-Cell
Rituximab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
131I-rituximab
Arm group label:
131I-rituximab
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
Criteria for 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)
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Address:
City:
Seoul
Zip:
139-706
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hye Jin Kang, M.D.
Contact backup:
Last name:
Dong-Yeop Shin, M.D.
Investigator:
Last name:
Dong-Yeop Shin, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Sung Hyun Yang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Im Il Na, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Hyo-Rak Lee, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Sang Moo Lim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Chang Woon Choi, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Byung Il Kim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Ilhan Lim, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Seung-Sook Lee, M.D.
Email:
Sub-Investigator
Start date:
June 2012
Completion date:
June 2017
Lead sponsor:
Agency:
Korea Cancer Center Hospital
Agency class:
Other
Source:
Korea Cancer Center Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01678417
