Phase 2 N=206 Randomized Treatment

Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

Bottom Line

View on ClinicalTrials.gov: NCT00931918 ↗

Enrolled (actual)

206

Serious AEs

32.3%

Results posted

Jan 2017

Primary outcome: Primary: Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL) — NA; NA months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bortezomib (Drug); Rituximab (Drug); Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Prednisone (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Millennium Pharmaceuticals, Inc.
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)	NA; NA	—
PRIMARY Progression-Free Survival Rate	78; 82	—
SECONDARY Overall Survival	NA; NA	—
SECONDARY Overall Response Rate (ORR)	93; 90; 88; 84; 98; 96	—
SECONDARY Complete Response Rate	23; 16; 45; 56; 49; 56	—
SECONDARY Duration of Response	NA; NA	—
SECONDARY Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate	42; 37; 53; 59	—
SECONDARY Time to Progression (TTP)	NA; NA	—
SECONDARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category	100; 99; 88; 95; 71; 79	—
SECONDARY Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher	70; 86; 68; 69; 65; 70	—

Summary

This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.

Eligibility Criteria

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Inclusion Criteria

Patients with previously untreated DLBCL that has been sub classified as the non-GCB subtype.
At least 1 measurable tumor mass.
Availability of paraffin block with sufficient tumor tissue.
No evidence of central nervous system lymphoma.
Eastern Cooperative Oncology Group (ECOG) performance status of < or equal to 2.
Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Exclusion Criteria

Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL.
Peripheral neuropathy of Grade 2 or greater.
Known history of human immunodeficiency virus (HIV) infection, unless receiving highly active antiretroviral therapy (HAART).
Active infection requiring systemic therapy.
Major surgery within 2 weeks before first dose.
Patients with a left ventricular ejection fraction (LVEF) or less than 45%.
Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled cardiovascular conditions as described in the protocol.
History of allergic reaction/ hypersensitivity attributable to boron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00931918). 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.