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: Unknown
• Conditions: Relapsed or Refractory Marginal Zone B-cell Lymphoma
• Intervention / Treatment: Drug: 131I-rituximab

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • 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.
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 131I-rituximab; 131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles	Drug: 131I-rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate	International Working Group Response criteria	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		up to 5 years
Progression free survival		up to 5 years
Response duration		up to 5 years
Number of Adverse Events	grading the adverse events using CTCAE version 4.03	up to 5 years

Collaborators and Investigators

• Sponsor: Korea Cancer Center Hospital
• 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: October 1, 2011
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: September 4, 2012
• First Submitted That Met QC Criteria: September 4, 2012
• First Posted (Estimate): September 5, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 4, 2012
• Last Verified: August 1, 2012

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