Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

Part of paid clinical trials in Stanford, California.

Sponsor
University of Miami
Study ID
NCT00450385
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles
  • Doxorubicin — DRUG
    Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles
  • Prednisone — DRUG
    Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.
  • Vincristine — DRUG
    Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Study Details

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.

Key Dates

Start date
Apr 24, 2007
Status verified
May 2017
Primary completion
May 31, 2016
Completion
May 31, 2016

Study Design

Enrollment
57 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
University of MiamiMiamiFlorida33136-
University of Rochester Medical Center - Wilmot Cancer InstituteRochesterNew York14642-
Cleveland ClinicClevelandOhio44195-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-

Find similar trials in Stanford, CA

By research site
Stanford University· Stanford, CAUniversity of Miami· Miami, FLUniversity of Rochester Medical Center - Wilmot Cancer Institute· Rochester, NYCleveland Clinic· Cleveland, OHVanderbilt-Ingram Cancer Center· Nashville, TN

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