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A Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00078598
Recruitment Status : Unknown
Verified October 2004 by Corixa Corporation.
Recruitment status was:  Recruiting
First Posted : March 3, 2004
Last Update Posted : November 9, 2005
Sponsor:
Information provided by:

Study Description
Brief Summary:

A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United States and Europe.

Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will receive 375 mg/m2 of rituximab (US, Canada – Rituxan®; EU - Mabthera®), given as an IV infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the “dosimetric dose,” patients will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi (0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0, Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data from these three imaging timepoints, the patient’s weight, and platelet count, a patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq) will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In the second phase, termed the “therapeutic dose,” patients in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the patient-specific administered activity of Iodine 131–conjugated Tositumomab (35 mg).

Patients on study will be followed for response and safety at Week 7, Week 13, and every 3 months for the first and second years, every 6 months for the third year, and then annually for the fourth and fifth years. Patients will be followed for safety only annually for years 6-10.


Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Rituximab or Iodine I 131 Tositumomab Therapy Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma
Study Start Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • A histologically confirmed diagnosis of follicular lymphoma, Grade I, II, or III (WHO/REAL Classification) (follicular, small cleaved; follicular, mixed small-cleaved and large-cell; or follicular large-cell lymphoma in the International Working Formulation).
  • Recurrent lymphoma after one or two qualifying therapy regimen(s).
  • A performance status of at least 70% on the Karnofsky Scale.
  • An absolute neutrophil count > 1500 cells/mm3 and a platelet count > 100,000 cells/mm3.
  • Adequate renal function and adequate hepatic function.
  • Bi-dimensionally measurable disease with at least one lesion measuring > or equal to 2.0 x 2.0 cm (i.e., > 4.0 cm2) by CT scan.
  • HAMA negative.
  • At least 18 years of age.
  • Give written informed consent by signing an IRB/ethics committee approved informed consent form prior to study entry.

Exclusion Criteria

  • Histological transformation to diffuse,large cell lymphoma
  • More than 1 course of rituximab
  • Disease better treated with limited field therapy
  • Involvement of >25% of the intratrabecular marrow
  • Active infection
  • Significant cardiac disease
  • Prior ChemoRx, biological therapy, radiation Rx, or high dose systemic steroid therapy within 8 weeks
  • Prior radioimmunotherapy
  • History of another malignancy
  • HBsAg positivity
  • CNS involvement with lymphoma
  • Pregnant or nursing
  • Ascites by physical exam
  • Previous use of non-human monoclonal antibody therapy, known hypersensitive to murine proteins
  • Hydronephrosis
  • Radiotherapy to >25% of the blood forming marrow
  • Prior stem cell transplant
  • Failed stem cell harvest
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078598


Locations
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Barry Boatman, RN    404-303-3355    barry.boatman@northside.com   
Principal Investigator: Ronald Steis, MD         
United States, Ohio
Medical Oncology/Hematology Associates Not yet recruiting
Dayton, Ohio, United States, 45409
Contact: Cathy Hull, RN    937-223-2183      
Principal Investigator: Basel Yanes, MD         
United States, Washington
Madigan Army Medical Center Not yet recruiting
Tacoma, Washington, United States, 98431
Contact: Carol Dean, RN    253-968-3681    carol.ford@nw.amedd.army.mil   
Principal Investigator: David E McCune, MD, MPH         
St Mary Medical Center/Regional Cancer Center Recruiting
Walla Walla, Washington, United States, 99362
Contact: Cathy McCauley, RN    509-522-5993    mccaca@smmc.com   
Principal Investigator: Matthew Sacks, MD         
United States, West Virginia
West Virginia University/Mary Babb Randolph Cancer Center Not yet recruiting
Morgantown, West Virginia, United States, 26506
Contact: Robin Weisenborn, MT, CCRC    304-293-3709    WeisenbornR@rcbhsc.wvu.edu   
Principal Investigator: Solveig Ericson, MD, PhD         
Sponsors and Collaborators
Corixa Corporation
More Information

ClinicalTrials.gov Identifier: NCT00078598     History of Changes
Other Study ID Numbers: CCBX001-049
First Posted: March 3, 2004    Key Record Dates
Last Update Posted: November 9, 2005
Last Verified: October 2004

Keywords provided by Corixa Corporation:
Relapsed
Follicular

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