TheranosticTrials.org

Clinical Trial · NCT01446562

Y90 Ibritumomab Tiuxetan Post R-CHOP Chemotherapy for Advanced Stage Follicular Lymphoma

Overview

The primary objective of this study is to establish in a prospective phase II study the efficacy of 90Yttrium ibritumomab tiuxetan (90Y-RIT) after first line induction immuno-chemotherapy with R-CHOP in patients with high-risk advanced stage follicular non-Hodgkin's lymphoma, as assessed by the complete response rate.

Sponsor

Sunnybrook Health Sciences Centre

Phase

Phase 2

Contacts

Neil L Berinstein, MD, FRCP(C) (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01446562

Drug / Compound

ibritumomab tiuxetan

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

Eligibility

Inclusion

  • Biopsy demonstration of a CD20+ follicular non-Hodgkin's lymphoma diagnosed according to the World Health Organization (WHO) classification (grade I, II, or IIIa).
  • Bi-dimensional measurable disease by physical examination or radiographic evaluation (disease measurements at least 1.5 cm x 1.5 cm) or assessable disease on bone marrow evaluation.
  • Clinical criteria for therapeutic intervention, as previously reported by Hiddeman, including one of: the presence of B-symptoms, bulky disease (mediastinal lymphomas \>7.5 cm or other lymphomas \>5 cm in maximal diameter), an impairment of normal hematopoesis with hemoglobin \<10g/mm3, granulocytes \<1500/mm3, or platelets \<100,000/mm3, and/or a rapidly progressive disorder.
  • No prior radiotherapy or systemic therapy, including chemotherapy or immunotherapy (rituximab).
  • Adequate performance status (less than or equal to 2) according to the Eastern Cooperative Oncology Group (ECOG) (Zubrod) scale.
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must complete their therapy with 90Y Ibritumomab Tiuxetan at the participating centre. Induction chemotherapy with R-CHOP should also be completed at the participating centre, but exceptions can be made according to the discretion of the centre's primary investigator.
  • Intermediate or high-risk prognostic score (2-5 points) according to the follicular lymphoma international prognostic index (FLIPI).
  • Protocol treatment is to begin within 5 working days of patient registration
  • Patient consent must be obtained according to the Sunnybrook Health Sciences Centre Research Ethics Board requirements. A sample consent form is given in Appendix I. The patient must sign the consent form prior to registration.
  • Staging demonstration of advanced stage disease (stage III or IV) according to the Ann Arbor staging system.

Exclusion

  • Life expectancy less than or equal to 3 months, according to physician judgement.
  • Pregnancy or women who intend to breast-feed during the study period.
  • Known human immunodeficiency virus infection or hepatitis B viral infection.
  • Concurrent uncontrolled medical disease, including severe congestive heart failure, myocardial infarction within 6 months prior to enrollment, severe chronic renal failure, or active infection, with the severity of disease judged according to the discretion of the treating physician.
  • Follicular non-Hodgkin's lymphoma grade IIIb histology, according to the World Health Organization (WHO) classification.
  • Serum creatinine, alkaline phosphatase, or total bilirubin \>2.5 times the upper limit of the normal value, unless clearly related to lymphoma.