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:
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
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 April 17, 2014