Actively Recruiting
A Phase I/II Study of Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
Led by James Rubenstein · Updated on 2025-02-03
35
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
J
James Rubenstein
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of lenalidomide and Tafasitamab in patients with relapsed central nervous system (CNS) lymphoma, focusing on determining the maximum tolerated dose and the recommended dose for phase 2. This open-label, single-arm phase I/II study is the first to examine the use of a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients, as well as its combination with immunomodulatory imide drugs. The study also explores whether Tafasitamab can enhance blood-brain barrier permeability, which could have significant clinical implications. Participants receive Tafasitamab intravenously at a dose of 12 mg/kg on specific days across treatment cycles, combined with daily oral lenalidomide on days 1 to 21 of each cycle. The phase 1 part tests three dose levels of lenalidomide (10 mg, 15 mg, and 20 mg) alongside Tafasitamab to identify the optimal dose. After establishing this dose, phase 2 enrollment begins, continuing treatment until disease progression. Throughout the study, participants undergo various assessments including monitoring for dose-limiting toxicities, clinical benefit rate, treatment-related adverse events, progression-free survival, and overall survival. Additional tests explore drug penetration into cerebrospinal fluid, immune cell changes, tumor mutation profiles, and blood-brain barrier permeability using MRI and other biomarkers. Participants are followed for adverse events for 90 days after the last dose and for survival and disease status for up to one year, with the possibility to continue treatment as long as it is beneficial.
CONDITIONS
Brief Title
Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have relapsed primary or secondary CNS lymphoma of diffuse large B-cell lymphoma (DLBCL) type confirmed by imaging, eye exam, or cerebrospinal fluid tests.
- Concomitant systemic lymphoma or transformation from follicular lymphoma or chronic lymphocytic leukemia to aggressive B-cell lymphoma is allowed.
- Disease can be present in brain, leptomeninges/CSF, or intraocular compartments.
- Age 18 years or older.
- Anticipated survival greater than 2 months.
- ECOG performance status 0 or 1 (Karnofsky score 70% or higher).
- Adequate organ function including specific blood counts, liver enzymes, and kidney function.
- Ability to understand and sign informed consent.
- For chronic hepatitis B, viral load must be undetectable on therapy; for hepatitis C, must be treated and cured or have undetectable viral load if on treatment.
- Prior or concurrent malignancies allowed if they do not interfere with study safety or efficacy.
- Women of child-bearing potential and men must agree to use effective contraception and undergo pregnancy testing as required.
- Prior CNS lymphoma brain involvement must have had at least one prior systemic therapy; secondary CNS lymphoma must have had prior CNS-directed treatment.
- No limit on prior lines of therapy; prior IMiDs, anti-CD20 therapies, and stem cell transplants allowed.
- Recipients of prior stem cell transplant eligible if no graft versus host disease and off immunosuppressants.
You will not qualify if you...
- Recent systemic anti-cancer therapies within 2 weeks, radiation within 1 week, or antibody therapy within 4 weeks before first dose.
- Not recovered from prior treatment side effects worse than grade 1 (except hair loss).
- Currently receiving other investigational agents.
- Participation in other investigational studies within 4 weeks before treatment.
- History of HIV infection.
- CNS post-transplant lymphoproliferative disease.
- Known allergy to lenalidomide or Tafasitamab.
- Pregnant or women of child-bearing potential not using effective birth control.
- Breastfeeding mothers.
- Prior anti-CD19 based therapy including CAR-T therapy.
- Significant medical conditions or comorbidities that could risk patient safety, such as uncontrolled infections.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive Tafasitamab intravenously on specified days and take Lenalidomide orally daily for 21 days in each 28-day cycle. Treatment continues until disease progression or discontinuation.
Multiple visits in each cycle including days 1, 4, 8, 15, and 22 in cycle 1; days 1, 8, 15, and 22 in cycles 2 and 3; and days 1 and 15 for subsequent cycles
Duration - Up to 1 year after last dose
Participants are monitored for adverse events for 90 days after the last dose or decision to discontinue treatment, and for overall survival and disease status for up to 1 year after the last dose.
Regular follow-up visits for up to 1 year after treatment ends
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
H
Hayley Wallace
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here