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NCT04421560 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab, Ibrutinib and Rituximab in PCNSL
A Phase 1 study of Refractory Cancer and Primary Central Nervous System Lymphoma, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 4
- Study locations
NCT04421560: Recruiting Phase 1 study of Refractory Cancer and Primary Central Nervous System Lymphoma, sponsored by Dana-Farber Cancer Institute.
NCT04421560 is a Phase 1 study of Refractory Cancer and Primary Central Nervous System Lymphoma that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 37 participants, below the 128-participant average among 15 other Refractory Cancer trials with a reported enrollment target (71% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04421560, a Phase 1 study of Refractory Cancer and Primary Central Nervous System Lymphoma, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 4
- Study locations
Study Summary
This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL). The three drugs being used in the study are: * Pembrolizumab (MK3475) * Ibrutinib * Rituximab (or biosimilar)
Primary Outcome
The primary endpoint of PFS6 will be estimated as a binomial response proportion. The efficacy analysis population will include all evaluable patients (subjects will be considered evaluable for efficacy as long as they have received at least 75% of the planned doses for the 1st 6 weeks of treatment). Patients missing 6 months progression evaluation (for any reason) will be counted as progressors. For the primary analysis, the proportion of progression free patients at 6 months will be evaluated
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Rituximab
- DRUG Ibrutinib
Study Locations (4)
Massachusetts
- Dana Farber Cancer Institute - Boston
- Beth Israel Deaconess Medical Center - Boston
New York
- Columbia University Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2027-01-05 |
| Phase | Phase 1 |
What NCT04421560 shows while recruiting
NCT04421560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 128-participant average among 15 other Refractory Cancer trials with a reported enrollment target (71% lower).
The record links to 4 conditions, with Refractory Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04421560 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04421560 about?
NCT04421560 is a clinical study titled "Pembrolizumab, Ibrutinib and Rituximab in PCNSL". This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL). The three drugs being used in the study are: * Pembrolizumab (MK3475) * Ibrutinib * Rituximab (or biosimilar)
What is the current status of trial NCT04421560?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-08-01. Estimated completion is 2027-01-05.
What conditions does trial NCT04421560 study?
This clinical trial studies the following conditions: Refractory Cancer, Primary Central Nervous System Lymphoma, Relapsed Cancer, Recurrent Cancer.
What interventions are being tested in trial NCT04421560?
The interventions under investigation include: Pembrolizumab (DRUG), Rituximab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT04421560?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04421560 being conducted?
This trial has 4 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04421560's enrollment target sits among peer trials
37 10th of 15 higher than 6 of 15 other Refractory Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Cancer 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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