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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2018-10-24
NCT02048813Uploaded 03-31-2023
Access via NCI by Request
PDS UID: nci-data-513
A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)
Provider Information
Provider Data DescriptionThere are three different submissions (each with one dataset) for PMID 31365801 from ECOG-ACRIN trial E1912. This dataset, NCT02048813-D1, contains baseline, treatment, and efficacy data. Dataset NCT02048813-D2 contains toxicity data as shown in Table 2 of the paper. Dataset NCT02048813-D3 contains toxicity data as shown in supplemental Table S7 of the paper.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. It is not yet known whether fludarabine phosphate, cyclophosphamide, and rituximab may work better than ibrutinib and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
ConditionsAnemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Intervention TypeDrug: Cyclophosphamide
Drug: Fludarabine Phosphate
Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Other: Quality-of-Life Assessment
Biological: Rituximab
Drug(s)Drug: Ibrutinib
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Total Enrolled529
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm A (ibrutinib, rituximab) - Experimental
Arm B (rituximab, fludarabine phosphate, cyclophosphamide) - Active Comparator
Secondary IDNCI-2014-00118
PubMed (PMID)35427411
34865212
33439748
31365801
Collaborator(s)N/A
Region(s)United States
Age Range18 Years to 70 Years (ADULT, OLDER_ADULT)
Files: NCT02048813-D1
Data DictionaryNCT02048813-D1-Data-Dictionary_2.pdf
DATANCT02048813-D1-Dataset_3.txt
OTHERREADME.pdf
Files: NCT02048813-D2
Data DictionaryNCT02048813-D2-Data-Dictionary_2.pdf
DATANCT02048813-D2-Dataset_2.txt
OTHERREADME.pdf
Files: NCT02048813-D3
Data DictionaryNCT02048813-D3-Data-Dictionary_2.pdf
DATANCT02048813-D3-Dataset_2.txt
OTHERREADME.pdf
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