Status:
TERMINATED
Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)
Lead Sponsor:
University of Miami
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 b...
Detailed Description
In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 24 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00450385
Start Date
April 24 2007
End Date
May 1 2016
Last Update
June 23 2017
Active Locations (5)
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1
Stanford University
Stanford, California, United States, 94305
2
University of Miami
Miami, Florida, United States, 33136
3
University of Rochester Medical Center - Wilmot Cancer Institute
Rochester, New York, United States, 14642
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195