18 and older, any sex, with Marginal Zone Lymphoma or Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Complete Response Rate (CR) at 8 Weeks Post Single Agent InductionPrimary· 8 weeks post induction
Number of subjects that reached a complete response at the end of single agent induction as defined by a Lugano score of 3 or less on arm MONO - Monotherapy: Ublituximab.
Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake.
Patients who did not reach complete response at this point were then bridged to arm COMBO - Combotherapy: Ublituximab + Umbralisib.
Group
Value
95% CI
Ublituximab Only
2
Number of Participants With Complete Response Rate (CR) at up to 12 Months Post MONO - Monotherapy: Ublituximab or Combotherapy: Ublituximab + Umbralisib.Primary· up to 12 months post induction
Number of subjects that reached a complete response at up to 12 months post induction as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib.
Complete response assessed via PET CT scan utilizing the Lugano-Deauville Criteria where none of the lymphoma lesions had FDG ( FluoroDeoxyglucose) avidity greater than the liver uptake.
Group
Value
95% CI
Ublituximab Only
2
Ublituximab First, Then Ublituximab and Umbralisib
2
Overall Response Rates (ORR) for Number of ParticipantsSecondary· up to 12 months post induction
Overall Response Rate for number of subjects as defined by a Lugano score of 3 or less on arms MONO - Monotherapy: Ublituximab.OR Combotherapy: Ublituximab + Umbralisib.
Overall response rate assessed via PET CT utilizing Lugano deauvile criteria where lymphoma lesions had responded and would include complete response, partial response (\> 50% improvement) and stable disease (less than 50 % response)
Group
Value
95% CI
Ublituximab Only
2
Ublituximab First, Then Ublituximab and Umbralisib
2
Adverse events — posted to ClinicalTrials.gov
Time frame: 15 months, 9 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Ublituximab Only
Serious: 0/2 (0%)
Deaths: 0/2
Ublituximab First, Then Ublituximab and Umbralisib
This is an open-label, Phase II interventional study in order to assess efficacy and safety of single agent ublituximab as initial therapy for FL (Follicular lymphoma) and MZL (Marginal zone lymphoma ) with response driven addition of umbralisib for suboptimal response.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
· Phase 2, PHASE3
· not yet recruiting
NCT06864936 — Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis
· NA
· not yet recruiting
NCT07503873 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection
· Phase 2
· not yet recruiting
NCT07225361 — Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis
· Phase 4
· recruiting
NCT06629428 — Effects of Ublituximab on Motor Functions in Multiple Sclerosis
· EARLY_PHASE1
· recruiting
Other recruiting trials for Marginal Zone Lymphoma
Currently open trials in the same condition.
NCT06796998 — Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)
· Phase 2
· recruiting
NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
· Phase 2
· recruiting
NCT06860880 — Combating Cancer-Related Fatigue: A Personalized Supportive Care Program
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 21 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04508647.