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

Sponsor

Corixa Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00078598

Collaborator

(none)

506

Enrollment

Locations

101.2

Patients Per Site

Study Details

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

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 :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Northside Hospital	Atlanta	Georgia	United States	30342
2	Medical Oncology/Hematology Associates	Dayton	Ohio	United States	45409
3	Madigan Army Medical Center	Tacoma	Washington	United States	98431
4	St Mary Medical Center/Regional Cancer Center	Walla Walla	Washington	United States	99362
5	West Virginia University/Mary Babb Randolph Cancer Center	Morgantown	West Virginia	United States	26506