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NCT05351593 · ClinicalTrials.gov registry record · Phase 1
Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
A Phase 1 study of Primary Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma, sponsored by James Rubenstein.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT05351593: Recruiting Phase 1 study of Primary Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma, sponsored by James Rubenstein.
NCT05351593 is a Phase 1 study of Primary Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma that is actively recruiting participants, run by James Rubenstein. The registered enrollment target is 35 participants, below the 50-participant average among 12 other Primary Central Nervous System Lymphoma trials with a reported enrollment target (30% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05351593, a Phase 1 study of Primary Central Nervous System Lymphoma and Secondary Central Nervous System Lymphoma, is actively recruiting participants, sponsored by James Rubenstein.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single arm open-label multicenter phase I/II investigation of combination lenalidomide/Tafasitamab in patients with relapsed central nervous system (CNS) lymphoma. This is the first study to examine a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients as well as the combination of anti-CD19 antibody plus an Immunomodulatory imide drugs (IMiDs) in CNS lymphomas. This study will also test the novel hypothesis that Tafasitamab enhances blood-brain barrier permeability, a potential property that could have broad clinical implications.
Primary Outcome
Toxicities will be classified using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The DLT will be based on the tolerability observed during the first cycle. In order for a patient to be assessed for DLT, they must receive at least 75% of lenalidomide dose (16 of the planned 21 days of lenalidomide administration). The maximum tolerated dose of lenalidomide/Tafasitamab will be the highest dose at which fewer than one-third of patients experience dose limiting toxicit
Conditions Studied
Interventions
- DRUG Lenalidomide
- DRUG Tafasitamab
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-06-08 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT05351593 shows while recruiting
NCT05351593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 50-participant average among 12 other Primary Central Nervous System Lymphoma trials with a reported enrollment target (30% lower).
The record links to 3 conditions, with Primary Central Nervous System Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Lenalidomide is the first listed.
NCT05351593 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05351593 about?
NCT05351593 is a clinical study titled "Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma". This is a single arm open-label multicenter phase I/II investigation of combination lenalidomide/Tafasitamab in patients with relapsed central nervous system (CNS) lymphoma. This is the first study to examine a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients as well as the comb...
What is the current status of trial NCT05351593?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2022-06-08. Estimated completion is 2026-06-30.
What conditions does trial NCT05351593 study?
This clinical trial studies the following conditions: Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma, CNS Lymphoma.
What interventions are being tested in trial NCT05351593?
The interventions under investigation include: Lenalidomide (DRUG), Tafasitamab (DRUG).
Who is sponsoring clinical trial NCT05351593?
This trial is sponsored by James Rubenstein, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05351593 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05351593's enrollment target sits among peer trials
35 5th of 12 higher than 8 of 12 other Primary Central Nervous System Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Central Nervous System 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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