NCTN: 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) (E1912)
Study ID: E1912
NCT Number: NCT02048813
ECOG-ACRIN Cancer Research Group
Submitted in collaboration with the NCTN/NCORP Data Archive
Trial Title: NCTN: 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) (E1912)
Trial Description: This 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.
Clinical data presented in the following publication(s):
- PMID 31365801
- PMID 34407545
Disease type(s): Hematopoietic Neoplasm/Leukemia - Chronic Lymphoid Leukemia
Clinical dataset(s) included:
- NCT02048813-D1 (PMID 31365801): There are three different datasets (-D1 through -D3) for ECOG-ACRIN trial E1912's primary publication, PMID 31365801. This dataset, NCT02048813-D1, contains baseline characteristics, stratification factors, IGHV mutation status, treatment, second primary cancer, and efficacy data.
- NCT02048813-D2 (PMID 31365801): There are three different datasets (-D1 through -D3) for ECOG-ACRIN trial E1912's primary publication, PMID 31365801. This dataset, NCT02048813-D2, contains grade 3 and above toxicity data as shown in Table 2 of the paper.
- NCT02048813-D3 (PMID 31365801): There are three different datasets (-D1 through -D3) for ECOG-ACRIN trial E1912's primary publication, PMID 31365801. This dataset NCT02048813-D3 contains worst grade, treatment-related toxicity data as shown in supplemental Table S7 of the paper.
- NCT02048813-D4 (PMID 34407545): There are two different datasets (-D4 and -D5) for ECOG-ACRIN trial E1912's publication, PMID 34407545, reporting on measurable residual disease and progression-free survival. This dataset, NCT02048813-D4, contains baseline characteristics, baseline leukocytes, thymidine kinase, and survival data for patients with MRD data that were not already included in NCT02048813-D1.
- NCT02048813-D5 (PMID 34407545): There are two different datasets (-D4 and -D5) for ECOG-ACRIN trial E1912's publication, PMID 34407545, reporting on measurable residual disease and progression-free survival. This dataset, NCT02048813-D5, contains longitudinal measurable residual disease data.
You are encouraged to view the PDF data dictionaries found in the "Documents" tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).
- Type: Interventional
- Archive: The database of Genotypes and Phenotypes (dbGaP)