Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma

Part of paid clinical trials in San Francisco, California.

Sponsor
James Rubenstein
Study ID
NCT05351593
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • CNS Lymphoma
  • Primary Central Nervous System Lymphoma
  • Secondary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tafasitamab — DRUG
    Given IV
  • Lenalidomide — DRUG
    Given Orally

Study Details

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.

Key Dates

Start date
Jun 8, 2022
Status verified
Jan 2025
Primary completion
Sep 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Tafasitamab, Lenalidomide)
    Participants will be given 12mg of Tafasitamab on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2 \& 3, and days 1 and 15 for any cycle thereafter. Participants will also be given daily Lenalidomide on days 1-21 of each cycle.
  • Experimental: Phase 2 (Tafasitamab, Lenalidomide)
    Participants will be given 12mg of Tafasitamab on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2 \& 3, and days 1 and 15 for any cycle thereafter. Participants will also be given daily Lenalidomide on days 1-21 of each cycle at the recommended phase 2 dose.

Primary Outcome Measure

Proportion of participants with dose limiting toxicities (DLTs) (Phase 1) [ Time Frame: Up to 1 cycle (1 cycle is equal to 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Hayley Wallace
[email protected]
877-827-3222
[email protected]
James Rubenstein, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CA

Related Studies