A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
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ClinicalTrials.gov Identifier: NCT01855750 |
Recruitment Status :
Completed
First Posted : May 16, 2013
Results First Posted : March 19, 2019
Last Update Posted : April 13, 2020
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Sponsor:
Janssen Research & Development, LLC
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Lymphoma |
Interventions |
Drug: Ibrutinib Drug: Placebo Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone (or equivalent) |
Enrollment | 838 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Treatment Arm B: Ibrutinib+R-CHOP | Treatment Arm A: Placebo+R-CHOP |
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Participants received ibrutinib 560 milligram (mg) (4*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle). | Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle). |
Period Title: Overall Study | ||
Started | 419 | 419 |
Treated | 416 [1] | 418 [2] |
Completed | 0 | 0 |
Not Completed | 419 | 419 |
Reason Not Completed | ||
Death | 78 | 78 |
Lost to Follow-up | 9 | 23 |
Withdrawal by Subject | 35 | 28 |
Sponsor ends the study | 297 | 290 |
[1]
3 participants not treated:2 withdrew consent and 1 not treated per Sponsor/investigator's decision.
[2]
1 participant not treated: withdrew consent.
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Baseline Characteristics
Arm/Group Title | Treatment Arm B: Ibrutinib+R-CHOP | Treatment Arm A: Placebo+R-CHOP | Total | |
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Participants received ibrutinib 560 milligram (mg) (4*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle). | Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m^2) intravenously (IV), cyclophosphamide 750 mg/m^2 IV, doxorubicin 50 mg/m^2 IV, and vincristine 1.4 mg/m^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle). | Total of all reporting groups | |
Overall Number of Baseline Participants | 419 | 419 | 838 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 419 participants | 419 participants | 838 participants | |
61.1 (12.57) | 58.8 (13.57) | 59.9 (13.12) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 419 participants | 419 participants | 838 participants | |
Female |
198 47.3%
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193 46.1%
|
391 46.7%
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Male |
221 52.7%
|
226 53.9%
|
447 53.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 419 participants | 419 participants | 838 participants | |
Hispanic or Latino |
17 4.1%
|
13 3.1%
|
30 3.6%
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Not Hispanic or Latino |
388 92.6%
|
396 94.5%
|
784 93.6%
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Unknown or Not Reported |
14 3.3%
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10 2.4%
|
24 2.9%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 419 participants | 419 participants | 838 participants | |
White |
237 56.6%
|
250 59.7%
|
487 58.1%
|
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Black or African American |
4 1.0%
|
4 1.0%
|
8 1.0%
|
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Asian |
166 39.6%
|
160 38.2%
|
326 38.9%
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|
American Indian or Alaska Native |
2 0.5%
|
1 0.2%
|
3 0.4%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Other |
1 0.2%
|
1 0.2%
|
2 0.2%
|
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Unknown |
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Not reported |
7 1.7%
|
2 0.5%
|
9 1.1%
|
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Multiple |
2 0.5%
|
1 0.2%
|
3 0.4%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 419 participants | 419 participants | 838 participants |
Argentina |
1 0.2%
|
1 0.2%
|
2 0.2%
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Australia |
12 2.9%
|
8 1.9%
|
20 2.4%
|
|
Belgium |
8 1.9%
|
7 1.7%
|
15 1.8%
|
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Brazil |
8 1.9%
|
4 1.0%
|
12 1.4%
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|
Canada |
12 2.9%
|
9 2.1%
|
21 2.5%
|
|
China |
104 24.8%
|
96 22.9%
|
200 23.9%
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Czech Republic |
18 4.3%
|
12 2.9%
|
30 3.6%
|
|
Denmark |
5 1.2%
|
6 1.4%
|
11 1.3%
|
|
Finland |
6 1.4%
|
8 1.9%
|
14 1.7%
|
|
France |
7 1.7%
|
4 1.0%
|
11 1.3%
|
|
Germany |
5 1.2%
|
8 1.9%
|
13 1.6%
|
|
Hungary |
5 1.2%
|
6 1.4%
|
11 1.3%
|
|
Israel |
11 2.6%
|
12 2.9%
|
23 2.7%
|
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Italy |
24 5.7%
|
18 4.3%
|
42 5.0%
|
|
Japan |
33 7.9%
|
40 9.5%
|
73 8.7%
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Mexico |
2 0.5%
|
1 0.2%
|
3 0.4%
|
|
Netherlands |
5 1.2%
|
1 0.2%
|
6 0.7%
|
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Norway |
1 0.2%
|
6 1.4%
|
7 0.8%
|
|
Poland |
15 3.6%
|
24 5.7%
|
39 4.7%
|
|
Russia |
19 4.5%
|
34 8.1%
|
53 6.3%
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|
Korea, Republic Of |
14 3.3%
|
11 2.6%
|
25 3.0%
|
|
Spain |
5 1.2%
|
7 1.7%
|
12 1.4%
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|
Sweden |
0 0.0%
|
1 0.2%
|
1 0.1%
|
|
Taiwan, Province Of China |
8 1.9%
|
9 2.1%
|
17 2.0%
|
|
Turkey |
27 6.4%
|
24 5.7%
|
51 6.1%
|
|
Ukraine |
10 2.4%
|
9 2.1%
|
19 2.3%
|
|
United Kingdom |
14 3.3%
|
17 4.1%
|
31 3.7%
|
|
United States |
40 9.5%
|
36 8.6%
|
76 9.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
Sponsor decided to stop the study as all participants had concluded study treatment and outcomes were not expected to change and study was considered as completed.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Name/Title: | Medical Officer |
Organization: | Janssen Research & Development, LLC |
Phone: | 844-434-4210 |
EMail: | ClinicalTrialDisclosure@its.jnj.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01855750 |
Other Study ID Numbers: |
CR102118 PCI-32765DBL3001 ( Other Identifier: Janssen Research & Development, LLC ) U1111-1139-6222 ( Other Identifier: Universal Trial Number ) 2013-000959-40 ( EudraCT Number ) |
First Submitted: | May 14, 2013 |
First Posted: | May 16, 2013 |
Results First Submitted: | February 22, 2019 |
Results First Posted: | March 19, 2019 |
Last Update Posted: | April 13, 2020 |