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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 2B
Study Completion Date
2008-10
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
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
RandomizationNa
Blinding MethodNone
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 Range18 Years and older (ADULT, OLDER_ADULT)
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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