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NCT01855750 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Lymphoma, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 838
- Enrollment target
- 20
- Study locations
NCT01855750: Completed Phase 3 study of Lymphoma, sponsored by Janssen Research & Development.
NCT01855750 is a Phase 3 study of Lymphoma that has completed, run by Janssen Research & Development. The registered enrollment target is 838 participants, above the 481-participant average among 299 other Lymphoma trials with a reported enrollment target (74% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01855750, a Phase 3 study of Lymphoma, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 838 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.
Primary Outcome
EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Placebo
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Ibrutinib
Study Locations (20)
California
- - Greenbrae
- - La Jolla
- - Los Angeles
- - Salinas
- - Stanford
Indiana
- - Fort Wayne
- - Goshen
- - Indianapolis
Connecticut
- - Danbury
- - Hartford
Georgia
- - Atlanta
- - Marietta
Louisiana
- - Baton Rouge
- - New Orleans
Arizona
- - Tucson
District of Columbia
- - Washington D.C.
Illinois
- - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 838 participants |
| Start Date | 2013-09-03 |
| Est. Completion | 2019-04-05 |
| Phase | Phase 3 |
What the finished NCT01855750 record still lists
NCT01855750 is an interventional study that assigns participants to a tested intervention. The registered 838 participants enrollment target is mid-sized for trials with a published cap, above the 481-participant average among 299 other Lymphoma trials with a reported enrollment target (74% higher).
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01855750 names 20 study sites across 11 states, led by California, Indiana, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01855750 about?
NCT01855750 is a clinical study titled "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". The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lympho...
What is the current status of trial NCT01855750?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 838 participants. The study started on 2013-09-03. Estimated completion is 2019-04-05.
What conditions does trial NCT01855750 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT01855750?
The interventions under investigation include: Cyclophosphamide (DRUG), Placebo (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT01855750?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01855750 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01855750's enrollment target sits among peer trials
838 9th of 299 higher than 291 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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