18 and older, any sex, with Marginal Zone Lymphoma or Waldenstrom Macroglobulinemia. 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.
Overall Response Rate (ORR) as Assessed by Revised Response Criteria for Non- Hodgkin's Lymphoma (Lugano Classification) and Consensus-Based 6th International Workshop on Waldenstrom's Macroglobulinemia (IWWM)Primary· Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years
ORR for MZL=percentage of participants with complete response (CR)/partial response (PR). ORR for WM=CR/PR/very good partial response (VGPR)/minor response (MR). Response assessed per revised Lugano Classification for MZL \&per IWWM for WM participants. Per Lugano criteria CR=complete disappearance of all evidence of disease \& disease-related symptoms. PR=regression of measurable disease \& no new disease sites. Regression=≥50% decrease in the sum of the products of the diameters (SPD) of index lesions, with no increase in size of other lymph nodes/liver/spleen.Per IWWM criteria CR=disappeara
Group
Value
95% CI
MZL: Umbralisib
37.5
8.5 – 75.5
WM: Umbralisib
30.0
6.7 – 65.2
Duration of Response (DOR)Primary· From the first demonstration of response to umbralisib till disease progression/death (up to approximately 4.2 years)
DOR is defined as the time from documentation of a response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.
Group
Value
95% CI
MZL: Umbralisib
21.2
3 – 33
WM: Umbralisib
13
5 – 14
Complete Response (CR) RateSecondary· Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years
CR rate is defined as percentage of participants who achieved CR. CR was assessed using Revised Response Criteria for Non- Hodgkin's Lymphoma (Lugano Classification) for participants with MZL and Consensus-Based 6th IWWM for participants with WM.
Per Lugano Classification, CR= the complete disappearance of all evidence of disease and disease-related symptoms i.e., liver/spleen non palpable and normal in size and disappearance of nodules related to lymphoma.
Per IWWM criteria, CR=disappearance of serum monoclonal IgM protein by immunofixation with a normal serum IgM level, liver/spleen non pa
Group
Value
95% CI
MZL: Umbralisib
12.5
0.3 – 52.7
WM: Umbralisib
0
NA – NA
Progression-Free Survival (PFS)Secondary· From date of randomization until the date of first documented progression (up to approximately 4.2 years)
PFS is defined as the interval from Cycle 1 (1 cycle = 28 days) Day 1 to the earlier of the first documentation of definitive disease progression or death from any cause. Assessment of progressive disease (PD) was based on Revised Response Criteria for non-Hodgkin's lymphoma, Lugano Classification for participants with MZL and consensus-based 6th IWWM for participants with WM.
Per Lugano Classification, PD was defined as the appearance of any new lesion more than 1.5 centimeters (cm) in any axis, even if other lesions are decreasing in size. At least a 50% increase from nadir in one of the fo
Group
Value
95% CI
MZL: Umbralisib
47.1
1.4 – 47.1
WM: Umbralisib
18.4
2.1 – 35.0
Time to Treatment Failure (TTF)Secondary· From first dose on Day 1 of Cycle 1 (28 days = 1 cycle) up to discontinuation of treatment (up to approximately 4.2 years)
TTF is defined as a composite endpoint measuring time from Cycle 1/Day 1 to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death. PD was assessed based on Revised Response Criteria for non-Hodgkin's lymphoma, Lugano Classification for participants with MZL and consensus-based 6th IWWM for participants with WM.
Per Lugano Classification, PD was defined as the appearance of any new lesion more than 1.5 cm in any axis, even if other lesions are decreasing in size. At least a 50% increase from nadir in one of the following: SPD of index lesions
Group
Value
95% CI
MZL: Umbralisib
13.1
1.4 – NA
WM: Umbralisib
6.5
2.1 – 15.9
Number of Participants With at Least One Adverse Event (AE)Secondary· From first dose of study treatment up to end of study (up to approximately 4.2 years)
An AE is any untoward medical occurrence in a participant that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Group
Value
95% CI
MZL: Umbralisib
8
WM: Umbralisib
13
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study treatment up to end of study (up to approximately 4.2 years).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MZL: Umbralisib
Serious: 1/8 (13%)
Deaths: 1/8
WM: Umbralisib
Serious: 0/13 (0%)
Deaths: 0/13
Serious adverse events (1 terms)
Reaction
System
MZL: Umbralisib
WM: Umbralisib
Colitis
Gastrointestinal disorders
—
—
Other adverse events (109 terms — click to expand)
This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come back or that has not responded to standard treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05152459 — Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma
· Phase 1, PHASE2
· withdrawn
NCT04635683 — Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or M
· Phase 1
· withdrawn
NCT04692155 — Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously U
· Phase 1, PHASE2
· terminated
NCT04783415 — Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma
· Phase 2
· active not recruiting
NCT04149821 — Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy
· Phase 2
· terminated
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
NCT06563596 — Epco, Zanu, Ritux for R/R FL or MZL
· Phase 2
· recruiting
Other TG Therapeutics, Inc. trials
Trials by the same sponsor.
NCT07220252 — Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
· Phase 2, PHASE3
· 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
NCT07211633 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ub
· Phase 3
· recruiting
NCT06680037 — A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
· Phase 1
· recruiting
NCT06433752 — A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Mult
· 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 TG Therapeutics, Inc.
Last refreshed: 23 June 2023
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/NCT03364231.