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Type(s) of Cancer
Lymphoma
Study Phase
Phase 2
Study Completion Date
October 2008
NCT00301821Uploaded 09-11-2019
Access via NCI by Request
PDS UID - nci-data-372
A Phase II Study of Epratuzumab, Rituximab (ER)-CHOP for Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Provider Information
Provider Data DescriptionNCT00301821-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.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset107
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNon-SDTM
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryRATIONALE: 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.
ConditionsLymphoma
Intervention TypeBiological: epratuzumab
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Total Enrolled107
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionEpratuzumab + Rituximab + CHOP - Experimental
Secondary IDNCI-2012-02685
PubMed (PMID)17099879
21383282
21673350
27282998
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files: NCT00301821-D2
Data DictionaryNCT00301821-D2-Data-Dictionary_0.pdf
DATANCT00301821-D2-Dataset_0.csv
OTHERREADME.pdf
Files: NCT00301821-D1
Data DictionaryNCT00301821-D1-Data-Dictionary_0.pdf
DATANCT00301821-D1-Dataset.csv
OTHERREADME.pdf
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