Tafasitamab Plus Lenalidomide for Relapsed CNS Lymphoma
This study is testing a new combination of two drugs, Tafasitamab and Lenalidomide, for people with central nervous system (CNS) lymphoma that has come back (relapsed). CNS lymphoma is a type of cancer that affects the brain or spinal cord. Tafasitamab is given through an IV, and Lenalidomide is taken by mouth. This is the first time these drugs are being studied together for this condition. Researchers want to find the safest dose and see how well this combination works. You may be able to join if you are 18 or older and have relapsed CNS lymphoma of the diffuse large B-cell lymphoma type. The study plans to enroll 35 participants.
- Study design
- This is a single-arm, open-label study, meaning all participants receive the same treatment and both you and the study team will know which drugs are being given. It aims to enroll 35 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for dose-limiting toxicities, maximum tolerated dose, and recommended phase 2 dose are measured for up to one 28-day cycle.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
At a glance
Conditions
NCT05351593
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of California, San Francisco
San Francisco, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- James Rubenstein, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Proportion of participants with dose limiting toxicities (DLTs) (Phase 1)Up to 1 cycle (1 cycle is equal to 28 days)
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 toxicity. If multiple toxicities are seen, the presence of dose limiting toxicity should be based on the most severe toxicity experienced.
- Maximum Tolerated Dose (MTD) (Phase 1)Up to 1 cycle (1 cycle is equal to 28 days)
The MTD is the highest dose at which no more than one instance of a DLT is observed among 6 participants treated.
- Recommended Phase 2 Dose (RP2D) (Phase1)Up to 1 cycle (1 cycle is equal to 28 days)
The RP2D is the dose at which the Phase 2 portion of the study will begin enrolling. RP2D will be determined based on all data including available pharmacokinetics (PK), pharmacodynamic (PD), target engagement, efficacy, safety and tolerability data collected during Phase 1
- Percentage of participants with demonstrated Clinical Benefit Rate (CBR) (Phase 2)Up to 3 months
Response to the combination lenalidomide/Tafasitamab treatment is defined as achieving clinical benefit better at three months restaging. That is overall tumor shrinkage within three months of treatment initiation or stable disease at three months restaging. Response criteria will be graded using the Cytologic Response Criteria, Neurologic Response Criteria, and Radiographic Response Criteria developed by the International Workshop to Standardize Baseline Evaluation and Response Criteria in Primary CNS Lymphoma The response rate is defined as the proportion of study participants meeting the definition of response in Efficacy Analysis Set (EAS). Response rate will be summarized by percentage, along with the corresponding exact 95% confidence intervals (CIs).