Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP) (R-CHOP)
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|ClinicalTrials.gov Identifier: NCT00450385|
Recruitment Status : Terminated (Investigator Decision due to insufficient accrual.)
First Posted : March 22, 2007
Results First Posted : June 23, 2017
Last Update Posted : June 23, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Vincristine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP|
|Actual Study Start Date :||April 24, 2007|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
Patients will receive R-CHOP for 6 to 8 cycles:
Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
Other Name: Rituxan
Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
Other Name: Cytoxan
Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
Other Name: Adriamycin
Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
Other Name: Deltasone
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles
Other Name: Oncovin
- Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy. [ Time Frame: 30 months ]The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.
- Usefulness of Biomarkers Associated With Anti-Tumor Effects of Rituximab in Predicting Overall Survival in DLBCL Patients Receiving R-CHOP Therapy [ Time Frame: 24 Months ]The investigators aim to determine the usefulness of biomarkers associated with the antitumor effects of rituximab (e.g. immunoglobulin GFc receptor genotypes, CD20 protein expression and gene expression profiles) to predict overall survival of DLBCL patients treated with R-CHOP therapy and followed for at least 24 months or until death.
- Comparison of the Ability of Constructed Survival Models to Predict Overall Survival in DLBCL Patients Receiving R-CHOP Therapy [ Time Frame: 2 Years ]The investigators will compare the ability of constructed survival models to predict survival in DLBCL patients receiving R-CHOP therapy
- Determination of the Ability of Models and/or Biomarkers Associated With Anti-Tumor Effects of Rituximab to Predict 24-month Time to Treatment Failure in DLBCL Patients Receiving R-CHOP Therapy [ Time Frame: 24 Months ]The investigators aim to determine the ability of the models and/or biomarkers associated with the anti-tumor effects of rituximab to predict 24-month time to treatment failure, defined as disease progression, death or initiation of new treatment.
- Overall Response Rate of Study Participants at the End of Protocol Therapy [ Time Frame: Up to 8 cycles, about 24 weeks ]Rate of participants achieving complete response (CR), complete response/unconfirmed (CRu) partial response (PR) according to Non-Hodgkin's Lymphoma response criteria.
- Number of Participants From Whom Fixed Tissue Samples Were Collected for Future Studies. [ Time Frame: Baseline ]Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies.
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|Ages Eligible for Study:||18 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450385
|United States, California|
|Stanford, California, United States, 94305|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, New York|
|University of Rochester Medical Center - Wilmot Cancer Institute|
|Rochester, New York, United States, 14642|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Study Chair:||Izidore S. Lossos, MD||University of Miami|
|Responsible Party:||Izidore Lossos, Professor, University of Miami|
|Other Study ID Numbers:||
SCCC-2006069 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20070073 ( Other Identifier: Western Institutional Review Board )
|First Posted:||March 22, 2007 Key Record Dates|
|Results First Posted:||June 23, 2017|
|Last Update Posted:||June 23, 2017|
|Last Verified:||May 2017|
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
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Topoisomerase II Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists