Actively Recruiting
Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
Led by James Rubenstein · Updated on 2025-02-03
35
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
J
James Rubenstein
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed primary or secondary CNS lymphoma of diffuse large B-cell lymphoma type confirmed by appropriate criteria
- Age 18 years or older
- Expected survival greater than 2 months
- ECOG performance status of 0 or 1 (Karnofsky score 70% or higher)
- Adequate organ function including ANC ≥ 1.5 x 10^9/L, platelets ≥ 50 x 10^9/L, bilirubin ≤ 1.5 times upper normal limit (unless Gilbert's syndrome), AST and ALT ≤ 3 times upper normal limit, and creatinine clearance ≥ 60 mL/min/1.73 m2
- Ability and willingness to sign informed consent
- Undetectable hepatitis B viral load on suppressive therapy if applicable
- Hepatitis C infection treated and cured or currently treated with undetectable viral load
- Prior or concurrent malignancies allowed if not interfering with study assessments
- Agreement to use contraception if of child-bearing potential or male participant
- Prior therapies including at least one systemic therapy for brain involvement or prior CNS-directed treatment for secondary CNS lymphoma
- No limit on number of prior therapies; prior IMiDs, rituximab, stem cell transplant allowed except prior anti-CD19 or CAR-T therapy
- Recipients of prior stem cell transplant eligible if no graft versus host disease and off immunosuppressants
You will not qualify if you...
- Received systemic anti-cancer therapy within 2 weeks, radiation within 1 week, or antibody therapy within 4 weeks prior to first dose
- Not recovered from prior anti-cancer therapy adverse events to grade 1 or baseline (except alopecia)
- Currently receiving other investigational agents
- Participated in investigational study with treatment or device within 4 weeks prior to first dose
- History of HIV infection
- Presence of CNS post-transplant lymphoproliferative disease
- Known allergy or hypersensitivity 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
- Any significant medical condition or comorbidity compromising safety such as uncontrolled serious infection
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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