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

NCT ID: NCT01678417

Last Updated: 2012-09-05

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma

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 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)
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

Principal Investigators

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Hye Jin Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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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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FL or MCL 131I-rituximab RIT

Identifier Type: -

Identifier Source: org_study_id