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A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen

Primary Purpose

Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Large-Cell, Follicular, Lymphoma, Follicular

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ibritumomab Tiuxetan
Iodine I 131 Tositumomab
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Small Cleaved-Cell, Follicular focused on measuring non-Hodgkin's Lymphoma, follicular lymphoma, BEXXAR, ZEVALIN, Iodine I 131 Tositumomab, Ibritumomab Tiuxetan, Follicular, mixed small-cleaved and large-cell, Diffuse large cell non-Hodgkin's lymphoma following or concurrent with a diagnosis of follicular lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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. Exclusion criteria: 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 treatment with any non-human, particularly murine monoclonal or polyclonal antibodies for either diagnostic or therapeutic purposes. This exclusion does not extend to the chimeric monoclonal antibody, Rituximab. 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.

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trials Call Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 26, 2006
Last Updated
April 15, 2015
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00319332
Brief Title
A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen
Official Title
A Multi-center, Randomized, Phase 3 Study of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients With Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
This study has been cancelled prior to enrollment
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Small Cleaved-Cell, Follicular, Lymphoma, Large-Cell, Follicular, Lymphoma, Follicular, Lymphoma, Non-Hodgkin
Keywords
non-Hodgkin's Lymphoma, follicular lymphoma, BEXXAR, ZEVALIN, Iodine I 131 Tositumomab, Ibritumomab Tiuxetan, Follicular, mixed small-cleaved and large-cell, Diffuse large cell non-Hodgkin's lymphoma following or concurrent with a diagnosis of follicular lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ibritumomab Tiuxetan
Intervention Type
Drug
Intervention Name(s)
Iodine I 131 Tositumomab
Primary Outcome Measure Information:
Title
The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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 treatment with any non-human, particularly murine monoclonal or polyclonal antibodies for either diagnostic or therapeutic purposes. This exclusion does not extend to the chimeric monoclonal antibody, Rituximab. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Charleston
State/Province
North Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

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A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen

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