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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00319332
First received: April 26, 2006
Last updated: January 24, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Lymphoma, Small Cleaved-Cell, Follicular
Lymphoma, Large-Cell, Follicular
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Drug: Ibritumomab Tiuxetan
Drug: Iodine I 131 Tositumomab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 350
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319332

Locations
United States, Iowa
GSK Clinical Trials Call Center
Iowa City, Iowa, United States, 52242
United States, Missouri
GSK Clinical Trial Call Center
St. Louis, Missouri, United States, 63110
United States, New York
GSK Clinical Trials Call Center
Buffalo, New York, United States, 14263
United States, North Carolina
GSK Clinical Trials Call Center
Charleston, North Carolina, United States, 29425
United States, Oregon
GSK Clinical Trial Call Center
Portland, Oregon, United States, 97213
United States, Tennessee
GSK Clinical Trial Call Center
Knoxville, Tennessee, United States, 37920
United States, Washington
GSK Clinical Trial Call Center
Seattle, Washington, United States, 98109
GSK Clinical Trials Call Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319332     History of Changes
Obsolete Identifiers: NCT00078676
Other Study ID Numbers: 393229/029, CCBX001-053
Study First Received: April 26, 2006
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Iodine
Cadexomer iodine
Iodine-131 anti-B1 antibody
Antibodies, Monoclonal
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 22, 2014