Completed

Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

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What is being tested

rituximab

+ cytarabine

+ liposomal cytarabine

BiologicalDrugRadiation
Who is being recruted

Immune System Diseases+6

+ Immunoproliferative Disorders

+ Lymphatic Diseases

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorBeth Israel Deaconess Medical Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2003

Actual date on which the first participant was enrolled.

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. * Determine the event-free survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. OUTLINE: This is an open-label, multicenter study. * Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36. * CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29. * Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Official TitleZevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma 
NCT00073957
Principal SponsorBeth Israel Deaconess Medical Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-Cell

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Beth Israel Deaconess Medical Center

Boston, United StatesSee the location
Suspended

Fletcher Allen Health Care - Medical Center Campus

Burlington, United States
Completed2 Study Centers