SWOG clinical trial number

A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Older Patients (>/= 65 Years of Age) with Chronic Lymphocytic Leukemia(CLL)

Abbreviated Title
Rand PIII Bendamustine/Rituximab vs. Ibrutinib/Rituximab vs. Ibrutinib for Untreated AML >/= 65
Status Notes
EFFECTIVE MONDAY, May 16, 2016 at 4:30 pm ET, A041202 will permanently close to new patient registration (Step 1).

Patients on treatment should continue to be treated and followed as required per protocol. Patients on Arm 1 who progress and who wish to crossover to receive ibrutinib alone will still be able to do so. Re-registration (Step 2) will remain open for crossover patients.

A registration closure notice will be included in the May 1, 2016 Alliance protocol posting and on the Alliance A041202 study page on the CTSU Web site thereafter.

Effective 12/28/15, A041202 permanently closed to new patient pre-registration (Step 0).

Questions may be directed to Samantha Sublett at ssublett@uchicago.edu or 773-834-4091
NCORP, Members, Medical Oncologists, CTSU, Affiliates

Research committees



Rituximab Bendamustine Ibrutinib

Eligibility Criteria Expand/Collapse

SWOG has endorsed 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


Long Term Follow-up from A041202, A Phase 3 Study of Bendamustine/Rituximab vs Ibrutinib or Ibrutinib/Rituximab Shows Continued Efficacy and Safety of Ibrutinib in Older Adults with CLL

J Woyach;G Burbano;A Ruppert;C Miller;N Heerema;W Zhao;A Wall;W Ding;N Bartlett;D Brander;P Barr;K Rogers;S Parekh;D Stephens;J Brown;G Lozanski;J Blachly;S Nattam;R Larson;H Erba;M Litzow;S Lugar;C Owen;C Kuzma;J Abramson;R Little;S Dinner;R Stone;G Uy;W Stock;S Mandrekar;J Byrd Blood Jan 12:blood.2023021959. doi: 10.1182/blood.2023021959. Online ahead of print

PMid: PMID38215395


Geriatric Assessment measures are predictive of outcomes in chronic lymphocytic leukemia

P Johnson;J Woyach;A Ulrich;V Marcotte;R Nipp;D Lage;A Nelson;R Newcomb;J Rice;M Lavoie;C Ritchie;R Stone;A Ruppert;S Mandrekar;J Byrd;A El-Jawahri;J Le-Rademacher;A Rosko;D Stephens J Geriatr Oncol. Jul;14(6):101538

PMid: PMID37329769


Long term results of A041202 show continued advantage of ibrutinib-based regimens compared with bendamustine plus rituximab chemoimmunotherapy

J Woyach;A Ruppert;N Heerema;W Zhao;A Booth;W Ding;N Bartlett;D Brander;P Barr;K Rogers;S Parikh;S Coutre;A Hurria;G Lozanski;S Nattam;R Larson;H Erba;M Litzow;C Owen;J Atkins;J Abramson;R Little;S Smith;R Stone;S Mandrekar;J Byrd American Society of Hematology (Dec 11-14, 2021, Atlanta, GA), oral, #639

Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202

A Ruppert;A Booth;W Ding;N Bartlett;D Brander;S Coutre;J Brown;S Nattam;R Larson;H Erba;M Litzow;C Owen;C Kusma;J Abramson;R Little;S Smith;R Stone;J Byrd;S Mandrekar;J Woyach Leukemia, Jul 17. doi: 10.1038/s41375-021-01342-x. Online ahead of print

PMid: PMID34274940


Ibrutinib alone or in combination with rituximab produces superior progression free survival compared with bendamustine plus rituximab in untreated older patients with chronic lymphocytic leukemia: Results of Alliance North American Intergroup Study A041202

J Woyach;A Ruppert;N Heerema;W Zhao;AM Booth;W Ding;N Bartlett;D Brander;P Barr;KA Rogers;S Parikh;S Coutre;A Hurria;S Nattam;RA Larson;HP Erba;M Litzow;C Owen;R Stone;S Mandrekar;J Byrd Blood 132:6; doi: https://doi.org/10.1182/blood-2018-99-116653; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), oral/plenary

Ibrutinib Regimens versus Chemoimmunotherapy in Older Patients with Untreated CLL

JA Woyach;AS Ruppert;NA Heerema;W Zhao;AM Booth;W Ding;NL Bartlett;D Brander;PM Barr;KA Rogers;SA Parikh;SE Coutre;A Hurria;JR Brown;G Lozanski;JS Blachly;H Ozer;B Major-Elechi;B Fruth;RA Larson;HP Erba;M Litzow;C Owen;C Kurzma;JS Abramson;RF Little;SE Smith;RM Stone;SJ Mandrekar;JC Byrd New England Journal of Medicine Dec 27;379(26):2517-2528

PMid: PMID30501481 | PMC number: PMC6325637