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An Open-Label, Randomized, Phase 2 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

Phase 2
18 Years
Open (Enrolling)
Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

Thank you

Trial Information

An Open-Label, Randomized, Phase 2 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

This study will be recruiting patients in Utah, Texas, Florida, Illinois, New Jersey and
Michigan. Please call 1-866-835-2233 for more information.

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

Inclusion Criteria:

- Patients with previously untreated DLBCL that has been sub classified as the non-GCB

- 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

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL).

Outcome Time Frame:

48 months

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

September 2015

Related Keywords:

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



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