NCT00078598

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
506

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 1, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2004

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2004

Completed
Last Updated

November 9, 2005

Status Verified

October 1, 2004

First QC Date

March 1, 2004

Last Update Submit

November 8, 2005

Conditions

Non-Hodgkin's Lymphoma

Keywords

RelapsedFollicular

Interventions

Rituximab or Iodine I 131 Tositumomab TherapyDRUG

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Medical Oncology/Hematology Associates

Dayton, Ohio, 45409, United States

NOT YET RECRUITING

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

NOT YET RECRUITING

St Mary Medical Center/Regional Cancer Center

Walla Walla, Washington, 99362, United States

RECRUITING

West Virginia University/Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-HodgkinRecurrence

Interventions

Rituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

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

Study Record Dates

First Submitted

March 1, 2004

First Posted

March 3, 2004

Study Start

April 1, 2004

Last Updated

November 9, 2005

Record last verified: 2004-10

Locations

US(5)