TheranosticTrials.org

Clinical Trial · NCT00073957

Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Overview

RATIONALE: Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan and rituximab, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.

Sponsor

Beth Israel Deaconess Medical Center

Phase

Phase 2

Contacts

Robin Joyce, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00073957

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

  • Anaplastic large B-cell
  • Immunoblastic
  • Absolute neutrophil count at least 1,500/mm\^3
  • Relapsed disease, defined as the following:
  • More than 4 weeks since prior therapy for lymphoma
  • Fertile patients must use effective contraception during and for 1 year after study participation
  • Negative pregnancy test
  • B-cell diffuse large cell variant
  • Lymphomatoid granulomatosis
  • Progressive disease, defined as the following:
  • Appearance of any new lesion during or at the end of therapy
  • Recovered from all prior therapy
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)Chemotherapy
  • 50% increase from nadir in the SPD of any previously identified abnormal node
  • More than 4 weeks since prior major surgery (except diagnostic surgery)Other
  • Lymphocyte count no greater than 5,000/mm\^3 (for patients with small lymphocytic lymphoma)
  • More than 8 weeks since prior phase II investigational drugs
  • At least 1 lesion at least 2.0 cm by CT scan
  • Bidimensionally measurable disease
  • WHO 0-2Life expectancy
  • Intravascular large B-cell
  • 50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node
  • Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion
  • Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment
  • 18 and overPerformance status
  • Less than 25% bone marrow involvement by lymphoma
  • T-cell/histiocyte-rich
  • Creatinine no greater than 2.0 mg/dLOther
  • Mediastinal (thymic) large cell
  • Platelet count at least 100,000/mm\^3Hepatic
  • CD20-positive disease by immunohistochemistry
  • Ineligible for myeloablative therapy OR refused transplantation
  • Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site
  • At least 3 monthsHematopoietic
  • Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:

Exclusion

  • No hypocellular bone marrow
  • No human antimurine antibody reactivityBiologic therapy
  • No CNS lymphoma
  • No prior autologous bone marrow transplantation
  • No concurrent serious nonmalignant disease or infection that would preclude study participation
  • No transformed lymphoma from indolent to aggressive
  • No prior radioimmunotherapy
  • No prior peripheral blood stem cell rescue
  • No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
  • No HIV- or AIDS-related lymphoma
  • Not specifiedRadiotherapy
  • No prior failed stem cell collection
  • No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrowSurgery
  • Not pregnant or nursing
  • No other concurrent antineoplastic therapy