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 Large B-Cell Lymphoma

Millennium Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: Rituximab; Drug: VELCADE; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01040871

26866138-LYM-2034

Details and patient eligibility

About

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)

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

VR-CAP

Experimental group

Description:

VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.

Treatment:

Drug: Doxorubicin

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Prednisone

Drug: VELCADE

R-CHOP

Active Comparator group

Description:

R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone

Treatment:

Drug: Vincristine

Drug: Doxorubicin

Drug: Rituximab

Drug: Cyclophosphamide

Drug: Prednisone