131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma
This study is currently recruiting participants.
Verified August 2012 by Korea Cancer Center Hospital
Sponsor:
Korea Cancer Center Hospital
Information provided by:
Korea Cancer Center Hospital
ClinicalTrials.gov Identifier:
NCT01678404
First received: September 4, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsed or Refractory Marginal Zone B-cell Lymphoma |
Drug: 131I-rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma |
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 Events [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]grading the adverse events using CTCAE version 4.03
| Estimated Enrollment: | 28 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2014 (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 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678404
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, 139-706 | |
| 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. | |
| Sub-Investigator: Im Il Na, M.D. | |
| Sub-Investigator: Hyo-Rak Lee, M.D. | |
| Sub-Investigator: Dong-Yeop Shin, M.D. | |
| Sub-Investigator: Sang Moo Lim, M.D. | |
| Sub-Investigator: Change Woon Choi, M.D. | |
| Sub-Investigator: Byung Il Kim, M.D. | |
| Sub-Investigator: Ilhan Lim, M.D. | |
| Sub-Investigator: Seung-Sook Lee, M.D. | |
Sponsors and Collaborators
Korea Cancer Center Hospital
Investigators
| Principal Investigator: | Hye Jin Kang, M.D. | Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01678404 History of Changes |
| Other Study ID Numbers: | MZL 131I-rituximab RIT |
| Study First Received: | September 4, 2012 |
| Last Updated: | September 4, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013