Trial · NCT05351593
Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
NCT05351593, Phase 1, Phase 2, Recruiting, James Rubenstein
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma. Trials, record NCT05351593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05351593
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
- NCT number
- NCT05351593
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 35 participants, estimated
- Lead sponsor
- James Rubenstein
- Conditions
- CNS Lymphoma, Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
- Interventions
- Tafasitamab, Lenalidomide
- First posted
- 2022-04-28
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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 |
| Primary | 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). |
| Secondary | Proportion of participants with Treatment-Related Adverse Events | Up to 90 days | Serious adverse events, adverse events which are \>=Grade 3, and adverse events resulting in discontinuation of treatment, withdrawal from the study, and deaths on-study will be used to determine the proportion of participants with treatment-related adverse events. Analyses will be performed based on the safety population. |
| Secondary | Median Progression-free survival (PFS) (Phase 2) | Up to 1 year | PFS is defined as the duration from first dose to disease relapse, progression, or death, whichever occurs first. The censoring time for PFS is set to be last study assessment for progression, and will be descriptively analyzed using Kaplan-Meier methods |
| Secondary | Median Overall Survival (OS) | Up to 1 year | OS is defined as the duration from first dose to death. The censoring time for OS is set to be the last study contact. OS will be descriptively analyzed using Kaplan-Meier methods. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05351593
GET https://conductscience.org/api/trials/v1/NCT05351593/registered