Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Lar

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, open-label, active-control, parallel-group, multicenter, multinational Phase 2 Study of the efficacy and safety of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Non-Germinal Center B-Cell (non-GCB) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Bortezomib; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Male or female patients 18 years or older.

• Newly Diagnosed non-GCB subtype of DLBCL (Stage II, III or IV).

• At least 1 measurable site of disease.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening.

• Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

• Prior treatment with VELCADE.

• Prior extended radiotherapy or chemotherapy for lymphoma

• More than 150 mg/m2 of prior doxorubicin

• Major surgery within 3 weeks of study.

• Peripheral neuropathy or neuralgia of Grade 2 or worse.

• Active CNS lymphoma

• Diagnosed or treated for a malignancy other than NHL, with some exceptions

• Pregnant or breast feeding

• Active systemic infection

• Documented of suspected human immunodeficiency virus (HIV)/AIDS

• Uncontrolled or severe cardiovascular disease

• Known allergies, hypersensitivity or intolerance to study drugs

• Serious medical condition that could interfere with study

• Concurrent treatment with another investigational agent