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A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Unique Dataset IDNCT00301821
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients107RandomizationNoPubMed (PMID)21673350.0
Study PhaseClinical Study Phase IIBBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeOpen Label StudyDataset TypeOther

Clinical Trial Title

A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

Trial Summary and Conditions

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy together with chemotherapy may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with combination chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.

Data Summary

See data dictionary for more details.

Study Objectives

OBJECTIVES: Primary: Assess the efficacy of epratuzumab and rituximab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (CHOP), as measured by 12-month, event-free survival, in patients with previously untreated stage II, III, or IV diffuse large B-cell lymphoma. Assess the use of positron emission tomography (PET) scan routinely early in treatment and after completion of treatment.> Assess the functional response rate (complete response, partial response, or stable disease by CT scan and PET negative) in patients treated with this regimen. Assess the safety of this treatment regimen. Secondary: Correlate laboratory prognostic factors for large cell lymphoma with clinical response to this regimen. OUTLINE: This is a multicenter study. Patients receive epratuzumab IV over 1 hour on day 1, rituximab IV over 4-8 hours on day 1 or days 1 and 2, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 or 2, and oral prednisone on days 1-5 or 2-6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.> After completion of study treatment, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 86 patients will be accrued for this study.

Outcome Measures

Primary: Event-free Survival After 12 Months [ Time Frame: From Baseline to 12 months ] Secondary: Overall Survival [ Time Frame: time from study entry to 36 months ] Progression-free Survival (PFS) [ Time Frame: the time from study entry to 36 months ] Overall Response Rate (ORR) [ Time Frame: Baseline to first 6 cycles of treatment ]

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

NCT00301821-D2-Dataset.csv (events) is one of 2 datasets associated with PubMed ID 21673350. This dataset contains information that will allow you to reproduce the adverse events reported.

Available Downloads: NCT00301821-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00301821-D2-Data-Dictionary_0.pdf

DATA: NCT00301821-D2-Dataset_0.csv


Available Downloads: NCT00301821-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00301821-D1-Data-Dictionary_0.pdf

DATA: NCT00301821-D1-Dataset.csv