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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

M

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)

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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