Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP) (R-CHOP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|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.
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|