Back to results

131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma

Primary Purpose

Relapsed or Refractory Marginal Zone B-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

131I-rituximab

About this trial

This is an interventional treatment trial for Relapsed or Refractory Marginal Zone B-cell Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Korea Cancer Center Hospital, Korea Institute of Radiological and Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

131I-rituximab

Arm Description

131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles

Outcomes

Primary Outcome Measures

Overall response rate

International Working Group Response criteria

Secondary Outcome Measures

Response duration

Progression free survival

Overall survival

Number of Adverse Events

grading the adverse events using CTCAE version 4.03

Full Information

NCT ID

NCT01678404

First Posted

September 4, 2012

Last Updated

September 4, 2012

Sponsor

Korea Cancer Center Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01678404

Brief Title

131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma

Official Title

A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

October 2011 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Korea Cancer Center Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed or Refractory Marginal Zone B-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

131I-rituximab

Arm Type

Experimental

Arm Description

131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles

Intervention Type

Drug

Intervention Name(s)

131I-rituximab

Primary Outcome Measure Information:

Title

Overall response rate

Description

International Working Group Response criteria

Time Frame

up to 5 years

Secondary Outcome Measure Information:

Title

Response duration

Time Frame

up to 5 years

Title

Progression free survival

Time Frame

up to 5 years

Title

Overall survival

Time Frame

up to 5 years

Title

Number of Adverse Events

Description

grading the adverse events using CTCAE version 4.03

Time Frame

up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hye Jin kang, M.D.

Phone

+82-2-970-1289

mdhyejin@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dong-Yeop Shin, M.D.

Phone

+82-2-970-1246

baramg@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hye Jin Kang, M.D.

Organizational Affiliation

Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences

City

Seoul

ZIP/Postal Code

139-706

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hye Jin Kang, M.D.

First Name & Middle Initial & Last Name & Degree

Dong-Yeop Shin, M.D.

First Name & Middle Initial & Last Name & Degree

Hye Jin Kang, M.D.

First Name & Middle Initial & Last Name & Degree

Sung Hyun Yang, M.D.

First Name & Middle Initial & Last Name & Degree

Im Il Na, M.D.

First Name & Middle Initial & Last Name & Degree

Hyo-Rak Lee, M.D.

First Name & Middle Initial & Last Name & Degree

Dong-Yeop Shin, M.D.

First Name & Middle Initial & Last Name & Degree

Sang Moo Lim, M.D.

First Name & Middle Initial & Last Name & Degree

Change Woon Choi, M.D.

First Name & Middle Initial & Last Name & Degree

Byung Il Kim, M.D.

First Name & Middle Initial & Last Name & Degree

Ilhan Lim, M.D.

First Name & Middle Initial & Last Name & Degree

Seung-Sook Lee, M.D.

12. IPD Sharing Statement

Learn more about this trial

131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma

We'll reach out to this number within 24 hrs