University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 13NHL-10-1

An Open-Label, Randomized, Phase II Study to Assess the Effectiveness of RCHOP With or Without Velcade in Previously Untreated Patients with Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma.

Type: Treatment
Phase: Phase II
Status: Not Open (Closed)
Treatments: Chemotherapy: Systemic
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Anil Tulpule, M.D.
Other Trial Staff:  Christine Duran, D.M., TehChun Wang, R.N.

Staff may log in to see study documents.

You may participate in this study if:
1Patients with previously untreated non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL)
2Male or female patient 18 years of age or older
3ECOG performance status < / = 2
4AGC >1000; platelets >70,000 (obtained within 21 days before enrollment)
5SGOT and SGPT < / = 4 x uln; bilirubin <1.5 x uln with a normal direct bilirubin (obtained within 21 days before enrollment)
6Calculated creatinine clearance = / > 20 ml/min (obtained within 21 days before enrollment)
7At least 1 measurable tumor mass >1.5 cm in the long axis and >1.0 cm in the short axis
8Availability of paraffin block with sufficient tumor tissue to allow for subtyping that can be submitted for central laboratory analysis
9Signed study-specific informed consent and HIPAA

You may not participate in this study if:
1Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose or evidence of active malignancy other than DLBCL. Patients are not excluded if they have had basal cell or squamous cell carcinoma of the skin that was completely resected, or any in-situ malignancy that was adequately treated.
2Peripheral neuropathy Gr 2 or greater due to any cause
3Known history of HIV infection, unless receiving highly active anti-retroviral therapy (HAART)
4Active infection requiring systemic therapy
5Serious medical or psychiatric illness likely to interfere with participation in this clinical study
6Major surgery within 2 weeks before Day 1 of Cycle 1
7LVEF <45%
8MI within 6 months of enrollment or NYHA Class III or IV heart failure, or evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, CHF, angina, or electrocardiographic evidence of acute ischemia or active clinically significant conduction system abnormalities.
9History of allergic reaction/hypersensitivity attributable to compounds containing oron, mannitol, polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.
10Concurrent treatment with another investigational agent
11Pregnant or breastfeeding women. Female patients who: [1] are post-menopausal for at least 1 year before the screening visit, or [2] are surgically sterile, or [3] if they are of childbearing potential, must agree to practice two effective methods of contraception from the time of signing the informed consent document through 30 days after the last dose of study drug, and agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized (i.e., status post-vasectomy), must [1] agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, or [2] agree to completely abstain from heterosexual intercourse.
12Evidence of CNS lymphoma

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.