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

November 8, 2005 updated by: Corixa Corporation

A Multi-Center, Randomized, Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

506

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Contact:
        • Principal Investigator:
          • Ronald Steis, MD
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Not yet recruiting
        • Medical Oncology/Hematology Associates
        • Contact:
          • Cathy Hull, RN
          • Phone Number: 937-223-2183
        • Principal Investigator:
          • Basel Yanes, MD
    • Washington
      • Tacoma, Washington, United States, 98431
        • Not yet recruiting
        • Madigan Army Medical Center
        • Contact:
        • Principal Investigator:
          • David E McCune, MD, MPH
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • St Mary Medical Center/Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthew Sacks, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Not yet recruiting
        • West Virginia University/Mary Babb Randolph Cancer Center
        • Contact:
        • Principal Investigator:
          • Solveig Ericson, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corixa Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Study Registration Dates

First Submitted

March 1, 2004

First Submitted That Met QC Criteria

March 2, 2004

First Posted (ESTIMATE)

March 3, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

November 9, 2005

Last Update Submitted That Met QC Criteria

November 8, 2005

Last Verified

October 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCBX001-049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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