TheranosticTrials.org

Clinical Trial · NCT01868035

Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP

Overview

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 Tositumomab (BEXXAR) on studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for Diffuse Large B-cell Non-Hodgkin's Lymphoma (NHL), and for long-term safety. Additionally laboratory evaluations consisting of a thyroid stimulating hormone (TSH) level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

GSK Clinical Trials (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT01868035

Drug / Compound

tositumomab

Isotope(s):
Target(s):
  • CD20 antigen
Ligand Class: Antibodies

Eligibility

Inclusion

  • 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
  • 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)
  • ≥60% performance status on the Karnofsky Performance Scale and an anticipated survival of at least 3 months
  • 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)

Exclusion

  • brain or leptomeningeal metastases at any time since diagnosis
  • New York Heart Association class III or IV heart disease or other serious illness
  • pregnant or breastfeeding
  • active bilateral obstructive hydronephrosis
  • prior radiation, prior biological therapy, or prior chemotherapy other than first-line CHOP
  • human immunodeficiency virus infection
  • 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)
  • active infection requiring intravenous anti-infectives
  • HAMA positive