TheranosticTrials.org

Clinical Trial · NCT00989664

Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-refractory Low-grade or Transformed Low-grade B-cell Non-Hodgkin's Lymphoma

Overview

The results from Phase 1/2 (RIT-I-000) and Phase 2 (RIT-II-001) studies of Tositumomab and Iodine I 131 Tositumomab (TST/I-131 TST) demonstrated that TST/ I-131 TST produced a high response rate in patients with chemotherapy-relapsed/refractory, low-grade or transformed low-grade Non-Hodgkin's Lymphoma (NHL). On the basis of these results this study was designed to compare the efficacy of TST/ I-131 TST to the last qualifying chemotherapy regimen in patients with chemotherapy-refractory, low-grade or transformed low-grade NHL.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

GSK Clinical Trials (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT00989664

Drug / Compound

tositumomab

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies

Eligibility

Inclusion

Inclusion criteria not yet provided.

Exclusion

  • Subjects with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. Bilateral posterior iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.
  • Prior radioimmunotherapy.
  • Current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
  • Subjects who are pregnant or nursing.
  • Previous allergic reactions to iodine. This does not include reactions to intravenous iodine-containing contrast materials.
  • Prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
  • Known brain or leptomeningeal metastases.
  • Cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
  • Prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
  • Evidence of active infection requiring intravenous (IV) antibiotics at the time of study entry.
  • De novo intermediate- or high-grade lymphoma.
  • Prior stem cell transplant.
  • Known HIV infection.
  • Progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with \>3500 cGy.
  • Active obstructive hydronephrosis.
  • New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.