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A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)

NCT ID: NCT01676558

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-06-30

Brief Summary

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Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status, refractoriness, and relapsed disease still remains. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.

Detailed Description

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Conditions

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Relapsed or Refractory Diffuse Large B Cell Lymphoma

Keywords

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diffuse large B cell lymphoma radioimmunotherapy 131I-rituximab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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131I-rituximab

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

Group Type EXPERIMENTAL

131I-rituximab

Intervention Type DRUG

Interventions

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131I-rituximab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diffuse large B cell lymphoma Elderly (\>65 years) or medically ineligible to standard cytotoxic chemotherapy due to poor performance status, or relapsed or refractory patients Eastern Cooperative Oncology Group performance status ≤ 2, age≥ 20 years Relapsed or refractory after autologous hematopoietic stem cell transplantation (auto-HSCT) in young patients with good performance status and indicated to high dose chemotherapy and auto-HSCT 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) Young patient with good performance status indicated to autologous hematopoietic stem cell transplantation irrespective of the failure of 1st line chemotherapy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Cancer Center Hospital

OTHER

Sponsor Role lead

Locations

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

Seoul, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hye Jin Kang, M.D.

Role: CONTACT

Phone: +82-2-970-1289

Email: [email protected]

Dong-Yeop Shin, M.D.

Role: CONTACT

Phone: +82-2-970-1246

Email: [email protected]

Facility Contacts

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Hye Jin Kang, M.D.

Role: primary

Dong-Yeop Shin, M.D.

Role: backup

Other Identifiers

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DLBCL_131I-rituximab RIT

Identifier Type: -

Identifier Source: org_study_id