Back to resultsA Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE™)
Primary Purpose
Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ofatumumab
ibrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Chronic Lymphocytic Leukemia focused on measuring Chronic, SLL, CLL, Ofatumumab, ibrutinib, RESONATE, Phase III, Leukemia, Lymphoma
Eligibility Criteria
Inclusion Criteria:
- ECOG performance status of 0-1.
- Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.
- Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.
- Must have received at least one prior therapy for CLL/SLL.
- Considered not appropriate for treatment or retreatment with purine analog based therapy.
- Measurable nodal disease by CT.
- Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.
Exclusion Criteria:
- Known CNS lymphoma or leukemia.
- No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
- Any history of Richter's transformation or prolymphocytic leukemia.
- Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
- Prior exposure to ofatumumab or to ibrutinib.
- Prior autologous transplant within 6 months prior to first dose of study drug.
- Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
- History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
- Serologic status reflecting active hepatitis B or C infection.
- Unable to swallow capsules or disease significantly affecting gastrointestinal function.
- Uncontrolled active systemic fungal, bacterial, viral, or other infection.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
- Requires anticoagulation with warfarin.
Sites / Locations
- Site #408
- Site #377
- Site #403
- Site #038
- Site #411
- Site #107
- Site # 379
- Site # 390
- Site # 391
- Site # 349
- Site # 130
- Site # 406
- Site # 059
- Site # 350
- Site # 200
- Site # 127
- Site # 197
- Site # 217
- Site # 402
- Site # 396
- Site # 410
- Site # 032
- Site # 381
- Site # 210
- Site # 404
- Site # 500
- Site # 503
- Site # 199
- Site # 501
- Site # 502
- Site # 509
- Site # 508
- Site # 504
- Site # 505
- Site # 506
- Site # 507
- Site # 393
- Site # 519
- Site # 511
- Site # 515
- Site # 516
- Site # 513
- Site # 510
- Site # 520
- Site # 518
- Site # 517
- Site # 570
- Site # 528
- Site # 096
- Site # 522
- Site # 523
- Site # 526
- Site # 524
- Site # 527
- Site # 529
- Site # 531
- Site # 535
- Site # 534
- Site # 533
- Site # 539
- Site # 540
- Site # 537
- Site # 536
- Site # 538
- Site # 549
- Site # 543
- Site # 551
- Site # 553
- Site # 546
- Site # 554
- Site # 550
- Site # 552
- Site # 544
- Site # 548
- Site # 545
- Site # 541
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ofatumumab (Arm A)
ibrutinib (Arm B)
Arm Description
An anti-CD20 monoclonal antibody
A Bruton Tyrosine Kinase Inhibitor
Outcomes
Primary Outcome Measures
PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
Secondary Outcome Measures
Overall Response Rate (ORR) by Independent Review Committee (IRC)
Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013
OS (Overall Survival)
OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm
Rate of Sustained Hemoglobin and Platelet Improvement
Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors.
Full Information
NCT ID
NCT01578707
First Posted
April 11, 2012
Last Updated
December 3, 2019
Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01578707
Brief Title
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Acronym
RESONATE™
Official Title
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
October 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacyclics LLC.
Collaborators
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Detailed Description
Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.
Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
Chronic, SLL, CLL, Ofatumumab, ibrutinib, RESONATE, Phase III, Leukemia, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
391 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ofatumumab (Arm A)
Arm Type
Active Comparator
Arm Description
An anti-CD20 monoclonal antibody
Arm Title
ibrutinib (Arm B)
Arm Type
Experimental
Arm Description
A Bruton Tyrosine Kinase Inhibitor
Intervention Type
Drug
Intervention Name(s)
ofatumumab
Intervention Description
The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)
Intervention Type
Drug
Intervention Name(s)
ibrutinib
Intervention Description
ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013
Description
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
Time Frame
Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) by Independent Review Committee (IRC)
Description
Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013
Time Frame
About 18 months after the first subject was enrolled
Title
OS (Overall Survival)
Description
OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm
Time Frame
OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up
Title
Rate of Sustained Hemoglobin and Platelet Improvement
Description
Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors.
Time Frame
From study initiation to study closure, including up to 6 years of study follow-up
Other Pre-specified Outcome Measures:
Title
Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up
Description
Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up
Time Frame
From study initiation to study closure, including up to 6 years of study follow-up
Title
Overall Response Rate (ORR) by Investigator
Description
Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up
Time Frame
From study initiation to study closure, including up to 6 years of study follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ECOG performance status of 0-1.
Diagnosis of CLL or SLL that meets IWCLL 2008 criteria.
Active disease meeting at least 1 of the IWCLL 2008 criteria for requiring treatment.
Must have received at least one prior therapy for CLL/SLL.
Considered not appropriate for treatment or retreatment with purine analog based therapy.
Measurable nodal disease by CT.
Patients must be able to receive outpatient treatment and laboratory monitoring at the institution that administers study drug for the entire study.
Exclusion Criteria:
Known CNS lymphoma or leukemia.
No documentation of cytogenetic and/or FISH in patient records prior to first dose of study drug.
Any history of Richter's transformation or prolymphocytic leukemia.
Uncontrolled Autoimmune Hemolytic Anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP).
Prior exposure to ofatumumab or to ibrutinib.
Prior autologous transplant within 6 months prior to first dose of study drug.
Prior allogeneic stem cell transplant within 6 months or with any evidence of active graft versus host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug.
History of prior malignancy, with the exception of certain skin cancers and malignancies treated with curative intent and with no evidence of active disease for more than 3 years.
Serologic status reflecting active hepatitis B or C infection.
Unable to swallow capsules or disease significantly affecting gastrointestinal function.
Uncontrolled active systemic fungal, bacterial, viral, or other infection.
History of stroke or intracranial hemorrhage within 6 months prior to the first dose of study drug.
Requires anticoagulation with warfarin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Szoke, MD
Organizational Affiliation
Pharmacyclics LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Site #408
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
Site #377
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Site #403
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Site #038
City
Stanford
State/Province
California
ZIP/Postal Code
94035
Country
United States
Facility Name
Site #411
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Site #107
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Site # 379
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Site # 390
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Site # 391
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Site # 349
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Site # 130
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Site # 406
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
Site # 059
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Site # 350
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site # 200
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Site # 127
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
Site # 197
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45291
Country
United States
Facility Name
Site # 217
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Site # 402
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Site # 396
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Site # 410
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5505
Country
United States
Facility Name
Site # 032
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site # 381
City
Laredo
State/Province
Texas
ZIP/Postal Code
78041
Country
United States
Facility Name
Site # 210
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Site # 404
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Site # 500
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Site # 503
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Site # 199
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Site # 501
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3109
Country
Australia
Facility Name
Site # 502
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Site # 509
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Site # 508
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Site # 504
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Site # 505
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Site # 506
City
Wein
ZIP/Postal Code
1160
Country
Austria
Facility Name
Site # 507
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
Site # 393
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Site # 519
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Site # 511
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Site # 515
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Site # 516
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Site # 513
City
Clermont Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
Site # 510
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Site # 520
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Site # 518
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Site # 517
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Site # 570
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Site # 528
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Site # 096
City
Galway
Country
Ireland
Facility Name
Site # 522
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Site # 523
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Site # 526
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Site # 524
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Site # 527
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Site # 529
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Site # 531
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Site # 535
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Site # 534
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site # 533
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Site # 539
City
Coruna
ZIP/Postal Code
15006A
Country
Spain
Facility Name
Site # 540
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Site # 537
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Site # 536
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Site # 538
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Site # 549
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Site # 543
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Site # 551
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Site # 553
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Site # 546
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Site # 554
City
Headington
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Site # 550
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Site # 552
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Site # 544
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Site # 548
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Site # 545
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Site # 541
City
Withington
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31512258
Citation
Munir T, Brown JR, O'Brien S, Barrientos JC, Barr PM, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Kipps TJ, Moreno C, Montillo M, Burger JA, Byrd JC, Hillmen P, Dai S, Szoke A, Dean JP, Woyach JA. Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019 Dec;94(12):1353-1363. doi: 10.1002/ajh.25638. Epub 2019 Oct 13.
Results Reference
derived
PubMed Identifier
31196847
Citation
Coutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.
Results Reference
derived
PubMed Identifier
30842083
Citation
Byrd JC, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Barr PM, Furman RR, Kipps TJ, Thornton P, Moreno C, Montillo M, Pagel JM, Burger JA, Woyach JA, Dai S, Vezan R, James DF, Brown JR. Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019 May 9;133(19):2031-2042. doi: 10.1182/blood-2018-08-870238. Epub 2019 Mar 6.
Results Reference
derived
PubMed Identifier
29470582
Citation
O'Brien SM, Jaglowski S, Byrd JC, Bannerji R, Blum KA, Fox CP, Furman RR, Hillmen P, Kipps TJ, Montillo M, Sharman J, Suzuki S, James DF, Chu AD, Coutre SE. Prognostic Factors for Complete Response to Ibrutinib in Patients With Chronic Lymphocytic Leukemia: A Pooled Analysis of 2 Clinical Trials. JAMA Oncol. 2018 May 1;4(5):712-716. doi: 10.1001/jamaoncol.2017.5604.
Results Reference
derived
PubMed Identifier
28751558
Citation
Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.
Results Reference
derived
PubMed Identifier
28373262
Citation
Barr PM, Brown JR, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Mulligan SP, Jaeger U, Furman RR, Cymbalista F, Montillo M, Dearden C, Robak T, Moreno C, Pagel JM, Burger JA, Suzuki S, Sukbuntherng J, Cole G, James DF, Byrd JC. Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL. Blood. 2017 May 11;129(19):2612-2615. doi: 10.1182/blood-2016-12-737346. Epub 2017 Apr 3.
Results Reference
derived
PubMed Identifier
26182309
Citation
Maddocks KJ, Ruppert AS, Lozanski G, Heerema NA, Zhao W, Abruzzo L, Lozanski A, Davis M, Gordon A, Smith LL, Mantel R, Jones JA, Flynn JM, Jaglowski SM, Andritsos LA, Awan F, Blum KA, Grever MR, Johnson AJ, Byrd JC, Woyach JA. Etiology of Ibrutinib Therapy Discontinuation and Outcomes in Patients With Chronic Lymphocytic Leukemia. JAMA Oncol. 2015 Apr;1(1):80-7. doi: 10.1001/jamaoncol.2014.218.
Results Reference
derived
PubMed Identifier
24881631
Citation
Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
Results Reference
derived
Learn more about this trial
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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