Phase 2
N=164
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
Diffuse Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01040871 ↗Enrolled (actual)
164
Serious AEs
36.0%
Results posted
Nov 2013
Primary outcome: Primary: Complete Response (CR) Rate — 64.5; 63.5 percentage of participants — p=0.915
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VELCADE (Drug); Rituximab (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Prednisone (Drug); Vincristine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate |
64.5; 63.5 | 0.915 |
| SECONDARY Overall Response Rate |
93.4; 98.6 | — |
| SECONDARY Rate of Durable Response |
53.9; 67.6 | — |
| SECONDARY Rate of Durable Complete Response |
44.7; 47.3 | — |
| SECONDARY Subsequent Anti-lymphoma Therapy Rate at 1-year |
71.1; 80.2 | — |
| SECONDARY Progression-free Survival (PFS)Rate at 1-year |
78.9; 83.9 | — |
| SECONDARY Overall Survival Rate at 1-year |
94.1; 84.2 | — |
| SECONDARY Change in Fatigue and Patient Utility Scores |
— | — |
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)
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01040871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.