Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

Not Recruiting

Trial ID: NCT00450385


The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.

Official Title

Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP

Stanford Investigator(s)

Ronald Levy, MD
Ronald Levy, MD

Robert K. and Helen K. Summy Professor in the School of Medicine

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD

Moghadam Family Professor


Inclusion Criteria:

   - 1. Diagnosis of diffuse large B-cell lymphoma, CD20-positive, according to the World
   Health Organization Classification, stages II-IV or limited stage I disease that is
   bulky (more than 10 cm) or with International Prognostic Index (IPI) score > 1.

   - 2. Patients must not have had prior chemotherapy, radiotherapy or immunotherapy. A
   short course (< 2 weeks) of corticosteroids is allowed.

   - 3. Adequate paraffin-embedded tumor specimen must be available for gene expression
   analysis and immunohistochemistry prior to initiation of therapy. (If the specimen is
   deemed inadequate, the subject can be retroactively screen failed, as this does not
   change the treatment regimen).

   - 4. Baseline measurements and evaluation must be obtained within 4 weeks before first

   - 5. Age >18 years.

   - 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.

   - 7. Adequate organ function:

      - White Blood Cells count (WBC) >2500/µL

      - Absolute Neutrophil Count (ANC) > 1000/µL (unless due to disease in marrow)

      - platelet count >100,000/µL (unless due to disease in marrow)

      - creatinine < 2.0 mg/dL,

      - bilirubin < 1.5 mg/dL (may be 1.5-3.0 mg/dl if due to liver involvement by

      - Serum Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic
      Transaminase (SGPT) <3 x upper limit of normal.

   - 8. Female patients must not be pregnant or breast feeding.

   - 9. Women of childbearing potential and men must be strongly advised to use an accepted
   and effective method of contraception.

   - 10. Patients must have left ventricular ejection fraction of >45%.

   - 11. Provision of written informed consent.

Exclusion Criteria:

   - 1. Patients with a second malignancy other than basal cell carcinoma of the skin or in
   situ carcinoma of the cervix unless the tumor was treated with curative intent at
   least two years previously; and; the patient continue to be free of evidence of

   - 2. Patients with HIV infection as these patients are managed on dedicated protocols.

   - 3. Patients with active central nervous system (CNS) lymphoma.


drug: cyclophosphamide

drug: prednisone

drug: Rituximab

drug: Doxorubicin

drug: Vincristine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

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