NCT00319332

Brief Summary

This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients, approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2005

Longer than P75 for phase_3

Geographic Reach
1 country

8 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

15.4 years

First QC Date

April 26, 2006

Last Update Submit

April 15, 2015

Conditions

Lymphoma, Small Cleaved-Cell, FollicularLymphoma, Large-Cell, FollicularLymphoma, FollicularLymphoma, Non-Hodgkin

Keywords

non-Hodgkin's Lymphomafollicular lymphomaBEXXARZEVALINIodine I 131 TositumomabIbritumomab TiuxetanFollicular, mixed small-cleaved and large-cellDiffuse large cell non-Hodgkin's lymphoma following or concurrent with a diagnosis of follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.

Secondary Outcomes (1)

  • The final analysis will be carried out when 130 events (progressive disease, death or subsequent therapy) have occurred in the control arm, expected approximately 18 months after last subject last visit.

Interventions

Ibritumomab TiuxetanDRUG
Iodine I 131 TositumomabDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or diffuse large cell lymphoma concurrent with or following the diagnosis of follicular lymphoma (WHO/REAL classification).
  • International Working Formulation histological equivalents of Follicular, small cleaved; Follicular, mixed small-cleaved and large-cell; follicular large-cell; or Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
  • Patients diagnosed with diffuse large cell lymphoma at study enrollment must have a historical or contemporaneous lymph node biopsy that demonstrates a diagnosis of follicular lymphoma.
  • Recurrent lymphoma after at least three qualifying therapy regimens including at least one Rituximab-containing regimen and at least one chemotherapy regimen.
  • The patient must have either not responded or responded with a duration of response of less than 6 months to a Rituximab-containing regimen, Performance status of at least 70% on the Karnofsky Scale and an anticipated survival of at least three months.
  • Bi-dimensionally measurable disease with at least one lesion measuring 4.0 cm2 by CT scan.
  • Absolute neutrophil count \>/= 1500 cells/mm3 and platelet count \>/=100,000/mm3 within 21 days prior to study enrollment.
  • Blood products and/or growth factors should not be taken within 4 weeks prior to blood draw.
  • Adequate renal function (defined as serum creatinine \<1.5 x upper limit of normal) and adequate hepatic function (defined as total bilirubin \<1.5x upper limit of normal and AST \<5x upper limit of normal) within 21 days prior to study enrollment.
  • Human Anti-Murine Antibody (HAMA) negative within 21 days prior to study enrollment.
  • Provision of informed consent as signified by a signed IRB approved consent form prior to any study-specific procedures being implemented.

You may not qualify if:

  • Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 90 days prior to study enrollment.
  • Hypocellular bone marrow (\</=15% cellularity or marked reduction in bone marrow precursors).
  • Prior myeloablative therapy.
  • History of failed stem cell collection.
  • Prior radiotherapy to fields encompassing more than 25% of the blood forming marrow.
  • Prior chemotherapy, biologic therapy, radiation therapy or steroid therapy for NHL within eight weeks prior to screening procedures.
  • Prior radioimmunotherapy.
  • Prior malignancy other than lymphoma, except for adequately treated basal cell or squamous cell skin cancer, in situ uterine cervical cancer, or other cancer for which the patient has been disease-free for five years.
  • Active infection requiring intravenous antibiotics at the time of study enrollment.
  • New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
  • HBsAg seropositivity.
  • Known HIV infection.
  • Known brain or leptomeningeal metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

GSK Clinical Trials Call Center

Iowa City, Iowa, 52242, United States

Location

GSK Clinical Trial Call Center

St Louis, Missouri, 63110, United States

Location

GSK Clinical Trials Call Center

Buffalo, New York, 14263, United States

Location

GSK Clinical Trials Call Center

Charleston, North Carolina, 29425, United States

Location

GSK Clinical Trial Call Center

Portland, Oregon, 97213, United States

Location

GSK Clinical Trial Call Center

Knoxville, Tennessee, 37920, United States

Location

GSK Clinical Trial Call Center

Seattle, Washington, 98109, United States

Location

GSK Clinical Trials Call Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetantositumomab I-131

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

September 1, 2005

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(8)