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NCT02315326 · ClinicalTrials.gov registry record · Phase 1
Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients With Newly Diagnosed or Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)
A Phase 1 study of Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Or Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL), sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 93
- Enrollment target
- 7
- Study locations
NCT02315326: Completed Phase 1 study of Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Or Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL), sponsored by Memorial Sloan Kettering Cancer Center.
NCT02315326 is a Phase 1 study of Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Or Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL) that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 93 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02315326, a Phase 1 study of Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Or Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL), has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 93 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to test any good or bad effects of the study drug called of ibrutinib (also known as Imbruvica™). At this stage of this trial, the study is investigating whether Ibrutinib can be incorporated into the established first-line chemotherapy regimen rituximab, methotrexate, vincristine, and procarbazine (R-VMP) in order to further refine the first-line induction therapy for PCNSL, as observed by a superior CRR (complete response rate) (ARM D RECRUITING ONLY)
Primary Outcome
A standard 3+3 design will be employed. Three dose levels of ibrutinib will be investigated. Patients will be treated in cohorts of size three to six and the dosage will be escalated if the clinical toxicity is acceptable. A dose-limiting toxicity (DLT) is defined as in any of the following during cycle 1: any grade 4 hematologic toxicity, grade 3 febrile neutropenia and grade 3 thrombocytopenia associated with bleeding or any grade 3 non-hematologic toxicity that does not respond to supportive
Conditions Studied
Interventions
- DRUG Ibrutinib
- DRUG procarbazine
- DRUG HD- Methotrexate (MTX)
- DRUG Rituximab + HD- Methotrexate (MTX)
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2014-12-08 |
| Est. Completion | 2026-01-28 |
| Phase | Phase 1 |
What the finished NCT02315326 record still lists
NCT02315326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% higher).
The record links to 2 conditions, with Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) appearing as the primary indexed condition, and to 4 interventions - of which Ibrutinib is the first listed.
NCT02315326 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT02315326 about?
NCT02315326 is a clinical study titled "Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Patients With Newly Diagnosed or Refractory/Recurrent Primary Central Nervous System Lymphoma (PCNSL) and Refractory/Recurrent Secondary Central Nervous System Lymphoma (SCNSL)". The purpose of this study is to test any good or bad effects of the study drug called of ibrutinib (also known as Imbruvica™). At this stage of this trial, the study is investigating whether Ibrutinib can be incorporated into the established first-line chemotherapy regimen rituximab, methotrexate, v...
What is the current status of trial NCT02315326?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 93 participants. The study started on 2014-12-08. Estimated completion is 2026-01-28.
What conditions does trial NCT02315326 study?
This clinical trial studies the following conditions: Adult Patients With Newly Diagnosed or Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL), Or Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL).
What interventions are being tested in trial NCT02315326?
The interventions under investigation include: Ibrutinib (DRUG), procarbazine (DRUG), HD- Methotrexate (MTX) (DRUG), Rituximab + HD- Methotrexate (MTX) (DRUG).
Who is sponsoring clinical trial NCT02315326?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02315326 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02315326's enrollment target sits among peer trials
93 624th of 2000 higher than 1,376 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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