Clinical trial NCT01040871: 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
Official title: A Randomized, Open-Label, Multicenter Phase 2 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2009-12-30
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Complete Response (CR) Rate
timeFrame: 6 cycles
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 6 cycles
measure: Rate of Durable Response
timeFrame: Median follow up approx. 12 months
measure: Rate of Durable Complete Response
timeFrame: Median follow up approx 12 months
measure: Subsequent Anti-lymphoma Therapy Rate at 1-year
timeFrame: 1 year
measure: Progression-free Survival (PFS)Rate at 1-year
timeFrame: 1 year
measure: Overall Survival Rate at 1-year
timeFrame: 1 year
measure: Change in Fatigue and Patient Utility Scores
timeFrame: 18-24 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Offner F, Samoilova O, Osmanov E, Eom HS, Topp MS, Raposo J, Pavlov V, Ricci D, Chaturvedi S, Zhu E, van de Velde H, Enny C, Rizo A, Ferhanoglu B. Frontline rituximab, cyclophosphamide, doxorubicin, and prednisone with bortezomib (VR-CAP) or vincristine (R-CHOP) for non-GCB DLBCL. Blood. 2015 Oct 15;126(16):1893-901. doi: 10.1182/blood-2015-03-632430. Epub 2015 Jul 31.