Status:
COMPLETED
Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lymphoma, Non-Hodgkin
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a multicenter study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tosit...
Detailed Description
This is a phase II, open-label, multicenter study of Iodine-131 Anti-B1 Antibody consolidation for 20 patients with diffuse large B-cell non-Hodgkin's lymphoma (NHL) achieving a partial response (PR),...
Eligibility Criteria
Inclusion
- male or female subjects age 18 to 80 years, inclusive, with any International Prognostic Index score; treated with 6 or more cycles of first-line CHOP chemotherapy and achieved a PR, CRu, or CR
- de novo diffuse large B-cell NHL according to the REAL classification; Ann Arbor stage III, stage IV, or bulky stage II disease (any mass ≥10 cm in diameter)
- less than an average of 25% of the intratrabecular marrow space involved by NHL in bilateral bone marrow biopsy specimens or \<10% involvement with NHL from unilateral bone marrow biopsy; tumor tissue expressing the CD20 antigen
- ≥60% performance status on the Karnofsky Performance Scale and an anticipated survival of at least 3 months
- absolute neutrophil count (ANC) ≥1500 cells/mm3 and platelet count ≥100,000/mm3
- adequate renal function (serum creatinine \<1.5 × upper limit of normal \[ULN\]) and hepatic function (total bilirubin ≤2.0 × ULN and aspartate aminotransferase \<5 × ULN)
Exclusion
- prior radiation, prior biological therapy, or prior chemotherapy other than first-line CHOP
- active bilateral obstructive hydronephrosis
- New York Heart Association class III or IV heart disease or other serious illness
- prior malignancy other than lymphoma (except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which they had been disease-free for \>5 years)
- human immunodeficiency virus infection
- HAMA positive
- brain or leptomeningeal metastases at any time since diagnosis
- active infection requiring intravenous anti-infectives
- pregnant or breastfeeding
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01868035
Start Date
May 1 2000
End Date
October 1 2012
Last Update
January 9 2017
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