Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine
Intervention description: Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles; Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles; Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles; Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.; Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage I adult diffuse large cell lymphoma

Summary:

      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.
    

Eligibility criteria:

        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
             treatment.

          -  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
                  lymphoma)

               -  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
             recurrence.

          -  2. Patients with HIV infection as these patients are managed on dedicated protocols.

          -  3. Patients with active central nervous system (CNS) lymphoma.