SWOG clinical trial number
CTSU/E1912

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)

Closed
Phase
Abbreviated Title
Rand PIII Ibrutinib-Based Tx vs. Fludarabine, Cyclophosphamide, Rituximab in Unrelated Youger CLL
Activated
02/15/2014
Participants
CTSU

Research committees

Leukemia

Treatment

Cyclophosphamide Allopurinol Fludarabine Phosphate Rituximab Ibrutinib

Eligibility Criteria Expand/Collapse

SWOG is participating in this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.

Publication Information Expand/Collapse

2021

Quality of Life in Patients <=70 Years of Age with Chronic Lymphocytic Leukemia Treated Frontline with Ibrutinib-Rituximab Versus Fludarabine Cyclophosphamide Rituximab: Analysis from ECOG-ACRIN E1912

P Pophali;X Wang;F Zhao;N Kay;C Hanson;M Thomas;S O'Brien;J Barrientos;E Paietta;J Leis;C Zhang;S Coutre;P Barr;A Cashen;A Mato;A Singh;R Little;H Erba;R Stone;M Litzow;M Tallman;T Shanfelt;L Wagner;L Wagner;L Wagner American Society of Hematology (Dec 11-14, 2021, Atlanta, GA), poster, #1562

Measurable Residual Disease Does Not Preclude Prolonged Progression-free Survival in CLL Treated with Ibrutinib

V Wang;C Hanson;R Tschumper;C Lesnick;E Braggio;E Paietta;S O'Brien;J Barrientos;J Leis;C Zhang;S Coutre;P Barr;A Cashen;A Mato;A Singh;M Mullane;H Erba;R Stone;M Litzow;M Tallman;T Shanafelt;N Kay Blood, Aug 18;blood.2020010146. doi: 10.1182/blood.2020010146. Online ahead of print.

PMid: PMID34407545

2019

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): A Trial of the ECOG-ACRIN Cancer Research Group (E1912)

T Shanafelt;XV Wang;N Kay;S O'Brien;J Barrientos;C Hanson;HP Erba;RM Stone;M Litzow;M Tallman Blood (2018) 132 (Supplement 1): LBA-4; American Society of Hematology Annual Meeting (Dec 7-10, 2019, Orlando, FL), oral

Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia

TD Shanafelt;XV Wang;C Hanson;S O'Brien;J Barrietos;J Barrietos;DF Jelinek;D Braggio;J Leis;CC Zhang;SE Coutre;P Barr;A Cashen;A Mato;A Singh;MP Mullane;RF Little;HP Erba;RM Stone;M Litzow;MS Tallman New England Journal of Medicine Aug 1;381(5):432-443

PMid: PMID31365801 | PMC number: PMC6908306

2018

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): A Trial of the ECOG-ACRIN Cancer Research Group (E1912)

T Shanafelt;V Wang;N Kay;C Hanson;S O'Brien;J Barrientos;H Erba;R Stone;M Litzow;M Tallman Blood 132:LBA-4; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), oral

2016

Novel associations between mutations, biological and clinical parameters in untreated CLL: Data from the ECOG-E1912, a Randomized Phase III Study of the ECOG-ACRIN Cancer Research Group

E Braggio;S Garcia;V Wang;L Bruins;C Lesnick;R Fonseca;N Kay;S O'Brien;T Shanafelt Blood 128:4373; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

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SWOG Clinical Trial Number
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Research Committee(s)
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Activated
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Accrual
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Phase
SWOG Clinical Trial Number
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Research Committee(s)
Leukemia
Activated
12/04/2020
Open