Completed

A Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma

What is being tested

cyclophosphamide

+ etoposide

+ iodine I 131 tositumomab

DrugRadiationProcedure

Who is being recruted

Blood Protein Disorders+33

+ Burkitt Lymphoma

+ Cardiovascular Diseases

From 18 to 60 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: February 1999

See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1999

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. To assess the progression-free survival of patients receiving 131 I labeled tositumomab antibody, etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation. II. To examine the potential efficacy of 131 I labeled tositumomab antibody, etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation. SECONDARY OBJECTIVES: I. To assess the overall survival of patients receiving 131 I labeled tositumomab antibody, etoposide (VP-16) and cyclophosphamide (CY) followed by autologous transplantation. II. To evaluate the toxicity and tolerability of the above therapy. OUTLINE: RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab intravenously (IV) on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplant on day 0. After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

Official TitleA Phase II Trial Evaluating The Efficacy of Radioiodinated Tositumomab (Anti-CD20) Antibody, Etoposide and Cyclophosphamide Followed by Autologous Transplantation, for Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT00073918

Principal SponsorFred Hutchinson Cancer Center

Last updated: January 27, 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

111 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 60 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

Blood Protein DisordersBurkitt LymphomaCardiovascular DiseasesDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersWaldenstrom MacroglobulinemiaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasTumor Virus InfectionsVascular DiseasesVirus DiseasesLymphoma, B-CellLymphoma, T-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, AnaplasticLymphoma, B-Cell, Marginal ZoneEpstein-Barr Virus InfectionsHemostatic DisordersLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma Cell

Criteria

7 inclusion criteria required to participate

Patients must have a histologically confirmed diagnosis of lymphoma expressing the cluster of differentiation (CD)20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) in accordance with current transplant standard of care for these patients

Note: Patients with clinically non-transformed follicular lymphomas do not require repeat biopsies for immunophenotyping since these tumors are uniformly reactive with the tositumomab antibody

Patients must have tumor burdens < 500cc by computed tomography (CT) or magnetic resonance (MRI) volumetric measurements and must not have splenomegaly at the time of enrollment; splenomegaly will be defined as a spleen volume > 2 standard deviations of the mean spleen volume to body weight ratio (mean = 3.84 cc/kg, SD = 1.53 cc/kg); thus, patients with > 6.9cc/kg will be defined as having splenomegaly; patients with splenomegaly that is thought to be due to G CSF/GM-CSF effect and not due to lymphomatous involvement of the spleen can been deemed eligible with the approval of an investigator

Patients must have normal renal function (creatinine [Cr] < 2.0)

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12 exclusion criteria prevent from participating

Circulating anti-mouse antibody (HAMA)

Systemic anti-lymphoma therapy given within 30 days prior to anticipated treatment date

Inability to understand or give an informed consent

Prior radiation > 20 Gy to any critical normal organ (e.g., lung, liver, spinal cord, or over 25% of red marrow)

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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

RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4. CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2. AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.

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 1 location

Suspended

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, United StatesOpen Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium in Google Maps

CompletedOne Study Center