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NCT06475235 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL
A Phase 1 study of Lymphoma and Primary Central Nervous System Lymphoma, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT06475235: Recruiting Phase 1 study of Lymphoma and Primary Central Nervous System Lymphoma, sponsored by Dana-Farber Cancer Institute.
NCT06475235 is a Phase 1 study of Lymphoma and Primary Central Nervous System Lymphoma that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 15 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06475235, a Phase 1 study of Lymphoma and Primary Central Nervous System Lymphoma, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is studying if the investigational drug, Pembrolizumab, in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects. This research study involves a combination of the below drugs: * Pembrolizumab (a type of monoclonal antibody) * Methotrexate (a type of anti-metabolite) * Temozolomide (a type of alkylating agent) * Rituximab (a type of antibody)
Primary Outcome
Dose-limiting toxicities (DLTs) will be defined as any grade ≥3 non-hematologic toxicity (with exceptions), grade 4 neutropenia lasting \>7 days or febrile neutropenia, grade 4 thrombocytopenia, grade 3 thrombocytopenia with clinically significant bleeding, any grade 5 toxicity or dose delays for \>14 consecutive days (related to AEs) with exceptions. Toxicities are to be assess according to the CTCAE v5.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Rituximab
- DRUG Temozolomide
- DRUG Methotrexate
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-10-18 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
What NCT06475235 shows while recruiting
NCT06475235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT06475235 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06475235 about?
NCT06475235 is a clinical study titled "Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL". This research study is studying if the investigational drug, Pembrolizumab, in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects. This research study involves a combination of the below drugs: * Pembrolizumab (a type of monoclonal antibody) * ...
What is the current status of trial NCT06475235?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-10-18. Estimated completion is 2027-06-30.
What conditions does trial NCT06475235 study?
This clinical trial studies the following conditions: Lymphoma, Primary Central Nervous System Lymphoma.
What interventions are being tested in trial NCT06475235?
The interventions under investigation include: Pembrolizumab (DRUG), Rituximab (DRUG), Temozolomide (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT06475235?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06475235 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06475235's enrollment target sits among peer trials
15 261st of 299 higher than 39 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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