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: Cancer Therapy
Phase: Phase II
Status: Open to Accrual
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., Teh-Chun Wang, R.N.

Staff may log in to see study documents.

You may participate in this study if:

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

You may not participate in this study if:

1	Diagnosed 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.
2	Peripheral neuropathy Gr 2 or greater due to any cause
3	Known history of HIV infection, unless receiving highly active anti-retroviral therapy (HAART)
4	Active infection requiring systemic therapy
5	Serious medical or psychiatric illness likely to interfere with participation in this clinical study
6	Major surgery within 2 weeks before Day 1 of Cycle 1
7	LVEF <45%
8	MI 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.
9	History 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.
10	Concurrent treatment with another investigational agent
11	Pregnant 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.
12	Evidence of CNS lymphoma

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

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