TheranosticTrials.org

Clinical Trial · NCT00110149

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

Overview

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90 ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.

Sponsor

Beth Israel Deaconess Medical Center

Phase

Phase 2

Contacts

Robin Joyce, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00110149

Drug / Compound

ibritumomab tiuxetan

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

ibritumomab tiuxetan

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

Eligibility

Inclusion

  • Bidimensionally measurable disease
  • Bilirubin ≤ 2.0 mg/dL
  • Discomfort
  • More than 4 weeks since prior major surgery except diagnostic surgeryOther
  • CD20-positive disease confirmed by immunohistochemistry or flow cytometry
  • Negative pregnancy test
  • Creatinine clearance \> 60 mL/minCardiovascular
  • Absolute neutrophil count \< 1,500/mm\^3
  • More than 3 monthsHematopoietic
  • Lymphocyte count \< 5,000/mm\^3 (for patients with SLL )Hepatic
  • B symptoms
  • Over 18Performance status
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)Chemotherapy
  • WBC ≥ 3,000/mm\^3
  • Disfigurement
  • Pain
  • History of failed stem cell collection
  • Creatinine ≤ 2.0 mg/dL OR
  • Prior myeloablative therapy
  • Rapidly progressive disease
  • ≤ 15% cellularity
  • Platelet count \< 100,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • More than 4 weeks since prior pegfilgrastim
  • WHO 0-2 OR
  • Undue anxiety related to not receiving treatment
  • Karnofsky 70-100%Life expectancy
  • Platelet count ≥ 100,000/mm\^3
  • Fertile patients must use effective contraception during and for at least 1 year after study treatment
  • Hypocellular marrow, as evidenced by 1 of the following:
  • At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan
  • Marked reduction in bone marrow precursors
  • Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone marrow aspiration and biopsy within the past 6 weeks
  • AST and ALT ≤ 2.5 times upper limit of normalRenal
  • Organ compromise
  • Systemic symptoms
  • Cytopenias
  • Grade1 or 2 follicular lymphoma
  • Requires antilymphoma therapy, as indicated by any of the following:
  • Small lymphocytic lymphoma (SLL)
  • Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the following histologic subtypes:
  • Marginal zone B-cell lymphoma
  • Malaise
  • ECOG 0-2 OR

Exclusion

  • No other serious nonmalignant disease that would preclude study participation
  • Not specifiedRadiotherapy
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • No other concurrent investigational agents
  • No clinically significant impaired bone marrow reserve as evidenced by any of the following:
  • No unstable angina pectoris
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to yttrium Y 90 ibritumomab tiuxetanOther
  • No other concurrent antilymphoma therapy
  • No other concurrent anticancer therapy
  • No symptomatic congestive heart failure
  • No prior chemotherapyEndocrine therapy
  • No other uncontrolled illnessBiologic therapy
  • No transformation to intermediate or high-grade NHL
  • No anti-murine antibody reactivity (in patients with prior exposure to murine antibodies or proteins)
  • No greater than 5,000/mm\^3 circulating tumor cells in peripheral blood
  • No prior systemic antilymphoma therapy
  • No prior external beam radiotherapy to \> 25% of active bone marrow (involved field or regional)Surgery
  • No cardiac arrhythmiaImmunologic
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No ongoing or active infection