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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Leukemia

A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Unique Dataset IDnci-data-400ClinicalTrial.gov IDNCT01886872
DownloadableNo
SponsorNational Cancer Institute (NCI)Data ProviderNational Cancer InstituteTotal Study Enrolled Patients547RandomizationYesPubMed (PMID)30501481.0
Study PhaseClinical Study Phase IIIBlinding MethodN/AType(s) of dataN/AIntervention TypeOtherDataset TypeOther

Clinical Trial Title

A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

Trial Summary and Conditions

This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as bendamustine hydrochloride, 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. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.

Data Summary

See data dictionary for more details.

Study Objectives

N/A

Outcome Measures

Progression Free Survival (PFS) [ Time Frame: Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years. ] The Kaplan-Meier method will be used to estimate the progression free survival distributions for each arm, with median estimates provided. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50% with >= 5000 B lymphocytes/mL in patients on Arm A or those on Arms 2 or 3 no longer receiving ibrutinib, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first.

ClinicalTrial.gov

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

NCI Description

Dataset NCT01886872-D5-Dataset.csv (bsl_qol) is one of 5 datasets associated with PubMed ID 30501481. This dataset contains information that will allow you to reproduce the baseline QOL analysis (table S3) in the supplemental materials.

Available Downloads: NCT01886872-D5

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

Data Dictionary: NCT01886872-D5-Data-Dictionary_0.pdf

DATA: NCT01886872-D5-Dataset_0.csv

OTHER: README.pdf

Available Downloads: NCT01886872-D4

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

Data Dictionary: NCT01886872-D4-Data-Dictionary_0.pdf

DATA: NCT01886872-D4-Dataset_0.csv

OTHER: README.pdf

Available Downloads: NCT01886872-D3

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

Data Dictionary: NCT01886872-D3-Data-Dictionary_0.pdf

DATA: NCT01886872-D3-Dataset_0.csv

OTHER: README.pdf

Available Downloads: NCT01886872-D2

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

Data Dictionary: NCT01886872-D2-Data-Dictionary_0.pdf

DATA: NCT01886872-D2-Dataset_0.csv

OTHER: README.pdf

Available Downloads: NCT01886872-D1

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

Data Dictionary: NCT01886872-D1-Data-Dictionary_0.pdf

DATA: NCT01886872-D1-Dataset_0.csv

OTHER: README.pdf