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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CCBX001-049

NCT ID:

NCT00078598

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Relapsed
  • Follicular
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Madigan Army Medical CenterTacoma, Washington  98431-5048
Northside HospitalAtlanta, Georgia  30342
Medical Oncology/Hematology AssociatesDayton, Ohio  45409
St Mary Medical Center/Regional Cancer CenterWalla Walla, Washington  99362
West Virginia University/Mary Babb Randolph Cancer CenterMorgantown, West Virginia  26506