131I-Rituximab consolidation in advanced diffuse large B-cell lymphoma

An investigator intitiated clnical trial for evaluating the efficacy and safety of 131I-Rituximab treatment as consolidation in the patients with CD20 positive advanced diffuse large B-cell lymphoma after standard combination chemotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0000526

Enrollment

Registered

2012-09-07

Start date

2006-05-15

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The patients is treated with 70mg of unlabeling rituximab to inhibit peripheral B-cell, and with acetaminophen 650mg per oral and chlorpheniramine 8mg iv for prophylaxis of anaphylaxis. Subsequ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. hitologically confirmed CD20 positive diffuse large B cell lymphoma 2. chemo-naive patient 3. no previous history of radiation therapy 4. no previous history of immunotherapy 5. measurable lesions?? ??? ??? ?? ? 6. =20 years old 7. Eastern Cooperative Oncology Group performance status = 2 8. adequate liver, kidney, bone marrow function - serum creatinine=1.5 mg/dl or creatinine clearance =60 ml/min - serum transaminases < 5 x upper normal limit - serum bilirubin < 4 mg/dl - neutrophil count=1,500/l, hemoglobin level=8 g/dl, and platelets=100,000/l 9. more than 3 months of expected overall survival. 10. patient who agree the purpose and intention of this clinical trial

Exclusion criteria

Exclusion criteria: 1. patients with involvement of cerebrospinal fluid 2. primary central nervous system lymphoma or diffuse large B cell lymphoma with central nervous system involvement 3. HIV positive 4. recent (<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded) 5. hemodynamically unstable due to the recent (<12 months) history of severe heart disease such as myocardial infarction 6. acute complications of severe lung or metabolic disease 7. Combined severe neurological or psychiatric disease 8. Unrecovered from infection or other medical disease 9. Recent (<30 days) history of enrollment of other clinical trial 10. more than 25% of lymphoma marrow involvement 11. Previous history drug allergy to the content of 131I-rituximab 12. Pregnant or breast-feeding woman 13. women of childbearing potential and men not employing adequate contraception

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
overall survival	—

Countries

Korea, Republic of

Contacts

Public ContactDong-Yeop Shin

Korea Institute of Radiological & Medical Sciences

Outcome results