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Status:

COMPLETED

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

Lead Sponsor:

Beth Israel Deaconess Medical Center

Conditions:

Lymphoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

OBJECTIVES: * Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab. * D...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:
  • B-cell diffuse large cell variant
  • Immunoblastic
  • Mediastinal (thymic) large cell
  • T-cell/histiocyte-rich
  • Anaplastic large B-cell
  • Intravascular large B-cell
  • Lymphomatoid granulomatosis
  • Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment
  • Relapsed disease, defined as the following:
  • Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site
  • 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
  • Progressive disease, defined as the following:
  • 50% increase from nadir in the SPD of any previously identified abnormal node
  • Appearance of any new lesion during or at the end of therapy
  • CD20-positive disease by immunohistochemistry
  • Bidimensionally measurable disease
  • At least 1 lesion at least 2.0 cm by CT scan
  • Less than 25% bone marrow involvement by lymphoma
  • No transformed lymphoma from indolent to aggressive
  • No HIV- or AIDS-related lymphoma
  • No hypocellular bone marrow
  • No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
  • No CNS lymphoma
  • Ineligible for myeloablative therapy OR refused transplantation
  • Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • WHO 0-2
  • Life expectancy
  • At least 3 months
  • Hematopoietic
  • Absolute neutrophil count at least 1,500/mm\^3
  • Lymphocyte count no greater than 5,000/mm\^3 (for patients with small lymphocytic lymphoma)
  • Platelet count at least 100,000/mm\^3
  • Hepatic
  • Bilirubin no greater than 2.0 mg/dL
  • Renal
  • Creatinine no greater than 2.0 mg/dL
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after study participation
  • No concurrent serious nonmalignant disease or infection that would preclude study participation
  • No human antimurine antibody reactivity
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • No prior autologous bone marrow transplantation
  • No prior peripheral blood stem cell rescue
  • No prior failed stem cell collection
  • 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
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Chemotherapy
  • See Disease Characteristics
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior radioimmunotherapy
  • No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow
  • Surgery
  • More than 4 weeks since prior major surgery (except diagnostic surgery)
  • Other
  • Recovered from all prior therapy
  • More than 4 weeks since prior therapy for lymphoma
  • More than 8 weeks since prior phase II investigational drugs
  • No other concurrent antineoplastic therapy

Exclusion

    Key Trial Info

    Start Date :

    December 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2012

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00073957

    Start Date

    December 1 2003

    End Date

    January 1 2012

    Last Update

    January 23 2018

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States, 02215

    2

    Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont, United States, 05401