We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Izidore Lossos, University of Miami

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 biomarkers associated with the anti-tumor effects of Rituximab.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Prednisone Drug: Vincristine Phase 2

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 models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab. The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: R-CHOP

Patients will receive R-CHOP for 6 to 8 cycles:

  • Rituximab 375 mg/m2 on day 1
  • Cyclophosphamide 750 mg/m2 IV on day 1
  • Doxorubicin 50 mg/m2 on day 1
  • Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
  • Prednisone 100 mg orally days 1-5, repeated every 21 days.
 Drug: Rituximab
Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
Other Name: Rituxan

Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
Other Name: Cytoxan

Drug: Doxorubicin
Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
Other Name: Adriamycin

Drug: Prednisone
Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
Other Name: Deltasone

Drug: Vincristine
Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles
Other Name: Oncovin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, California
Stanford University
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 Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Study Chair: Izidore S. Lossos, MD University of Miami
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Izidore Lossos, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00450385    
Other Study ID Numbers: 20061138
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
Keywords provided by Izidore Lossos, University of Miami:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists