131I-rituximab for Relapsed or Refractory Follicular or Mantle 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:
NCT01678417
First received: August 30, 2012
Last updated: September 4, 2012
Last verified: August 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsed or Refractory Follicular Lymphoma or Mantle 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 Follicular or Mantle 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 ]
Secondary Outcome Measures:
- Response duration [ 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 ]
- progression free survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 29 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (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 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678417
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. | |
| Sub-Investigator: Dong-Yeop Shin, 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: Sang Moo Lim, M.D. | |
| Sub-Investigator: Chang 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: | NCT01678417 History of Changes |
| Other Study ID Numbers: | FL or MCL 131I-rituximab RIT |
| Study First Received: | August 30, 2012 |
| Last Updated: | September 4, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Mantle-Cell 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 19, 2013