131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Korea Cancer Center Hospital
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014