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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2017-10
NCT00118209Uploaded 10-31-2020
Access via NCI by Request
PDS UID: nci-data-432
Phase III Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R With Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas
Provider Information
Provider Data Description Dataset NCT00118209-D1-Dataset.csv (master) is one of 2 datasets (NCT00118209-D1 and NCT00118209-D2) associated with PubMed ID 30939090. This dataset contains information that will allow you to reproduce the baseline characteristics table, primary and secondary analyses, and the primary cause of death.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving rituximab together with combination chemotherapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective when given with rituximab in treating diffuse large B-cell non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying rituximab when given together with two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.
ConditionsLarge B Cell Lymphoma
Intervention TypeBiological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: etoposide
Drug: filgrastim
Drug: pegfilgrastim
Drug(s)Drug: cyclophosphamide
Drug: doxorubicin
Drug: vincristine
Drug: prednisone
Drug: filgrastim
Drug: pegfilgrastim
Drug: etoposide
Total Enrolled524
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A - R-CHOP - Active Comparator
Arm B - DA-EPOCH-R - Experimental
Secondary IDCDR0000433265
PubMed (PMID)32232481
30939090
22180164
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT00118209-D1
Data DictionaryNCT00118209-D1-Data-Dictionary_3.pdf
DATANCT00118209-D1-Dataset_3.csv
OTHERREADME.pdf
Files: NCT00118209-D2
Data DictionaryNCT00118209-D2-Data-Dictionary_3.pdf
DATANCT00118209-D2-Dataset_3.csv
OTHERREADME.pdf
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