- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01678404
131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma
A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma
Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with variable differentiation status, which is distributed to a variety of organs.
A high response rate and long term survival is possible through surgery or radiation therapy alone in the case of limited disease. However frequent relapse and progression is observed despite of long term survival. The treatment after relapse has not been established yet.
So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with MZL.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hye Jin Kang, M.D.
- Phone Number: +82-2-970-1289
- Email: mdhyejin@gmail.com
Study Contact Backup
- Name: Dong-Yeop Shin, M.D.
- Phone Number: +82-2-970-1246
- Email: baramg@hanmail.net
Study Locations
-
-
-
Seoul, Korea, Republic of, 139-706
- Recruiting
- Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
-
Contact:
- Hye Jin Kang, M.D.
-
Contact:
- Dong-Yeop Shin, M.D.
-
Principal Investigator:
- Hye Jin Kang, M.D.
-
Sub-Investigator:
- Sung Hyun Yang, M.D.
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Sub-Investigator:
- Im Il Na, M.D.
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Sub-Investigator:
- Hyo-Rak Lee, M.D.
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Sub-Investigator:
- Dong-Yeop Shin, M.D.
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Sub-Investigator:
- Sang Moo Lim, M.D.
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Sub-Investigator:
- Change Woon Choi, M.D.
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Sub-Investigator:
- Byung Il Kim, M.D.
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Sub-Investigator:
- Ilhan Lim, M.D.
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Sub-Investigator:
- Seung-Sook Lee, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed marginal zone B-cell lymphoma
- relapsed or refractory patients after treatment including chemotherapy, radiation therapy, and surgery
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 131I-rituximab
131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: up to 5 years
|
International Working Group Response criteria
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: up to 5 years
|
up to 5 years
|
|
Progression free survival
Time Frame: up to 5 years
|
up to 5 years
|
|
Response duration
Time Frame: up to 5 years
|
up to 5 years
|
|
Number of Adverse Events
Time Frame: up to 5 years
|
grading the adverse events using CTCAE version 4.03
|
up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hye Jin Kang, M.D., Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, B-Cell, Marginal Zone
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- MZL 131I-rituximab RIT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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