Trial · NCT03364231
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
NCT03364231, Phase 2, Completed, TG Therapeutics, Inc.; results first posted 2023-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma. Trials, record NCT03364231. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03364231
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
- NCT number
- NCT03364231
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- TG Therapeutics, Inc.
- Conditions
- Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Non Follicular Indolent Non-Hodgkin Lymphoma
- Interventions
- Umbralisib
- First posted
- 2017-12-06
- Last updated
- 2023-06-23
- Results first posted
- 2023-06-23
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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=disappearance of serum monoclonal immunoglobulin M (IgM) protein by immunofixation with a normal serum IgM level. VGPR=reduction of monoclonal IgM protein \>90% from baseline. PR=reduction of monoclonal IgM protein between 50-90% from baseline with regression of measurable disease. Regression defined in similar manner as Lugano Classification. MR=reduction of monoclonal IgM protein \>25% but \<50% from baseline. |
| Primary | Duration of Response (DOR) | 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. |
| Secondary | Complete Response (CR) Rate | 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 palpable and normal in size and disappearance of nodes related to WM. |
| Secondary | Progression-Free Survival (PFS) | 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 following: SPD of index lesions, greatest transverse diameter (GTD) of any individual previously involved node, or GTD of any previously involved node provided that the GTD of that node is now ≥ 1.5 cm. Per IWWM criteria participants, PD was defined as more than 25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to the disease. |
| Secondary | Time to Treatment Failure (TTF) | 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, GTD of any individual previously involved node, or GTD of any previously involved node provided that the GTD of that node is now ≥ 1.5 cm. Per IWWM criteria PD was defined as more than 25% increase in serum IgM level from lowest nadir and/or progression in clinical features attributable to the disease. |
| Secondary | Number of Participants With at Least One Adverse Event (AE) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years | mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment. | percentage of participants | NUMBER |
| PRIMARY | Duration of Response (DOR) | From the first demonstration of response to umbralisib till disease progression/death (up to approximately 4.2 years) | mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment. 'Overall number of participants analyzed' is the number of participants with data available for analysis. | months | MEDIAN |
| SECONDARY | Complete Response (CR) Rate | Every 3 cycles (1 Cycle = 28 days) from Day 1 Cycle 1 up to approximately 4.2 years | mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | From date of randomization until the date of first documented progression (up to approximately 4.2 years) | mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF) | From first dose on Day 1 of Cycle 1 (28 days = 1 cycle) up to discontinuation of treatment (up to approximately 4.2 years) | mITT population included all participants who received at least one dose of study treatment and provided at least some post baseline efficacy assessment. | months | MEDIAN |
| SECONDARY | Number of Participants With at Least One Adverse Event (AE) | From first dose of study treatment up to end of study (up to approximately 4.2 years) | Safety population included all enrolled participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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) | MZL: Umbralisib | 37.5 | 95% Confidence Interval 8.5 to 75.5 | percentage of participants | |
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) | WM: Umbralisib | 30.0 | 95% Confidence Interval 6.7 to 65.2 | percentage of participants | |
| Duration of Response (DOR) | MZL: Umbralisib | 21.2 | Full Range 3 to 33 | months | |
| Duration of Response (DOR) | WM: Umbralisib | 13 | Full Range 5 to 14 | months | |
| Complete Response (CR) Rate | MZL: Umbralisib | 12.5 | 95% Confidence Interval 0.3 to 52.7 | percentage of participants | |
| Complete Response (CR) Rate | WM: Umbralisib | 0 | 95% Confidence Interval NA to NA | percentage of participants | |
| Progression-Free Survival (PFS) | MZL: Umbralisib | 47.1 | Full Range 1.4 to 47.1 | months | |
| Progression-Free Survival (PFS) | WM: Umbralisib | 18.4 | Full Range 2.1 to 35.0 | months | |
| Time to Treatment Failure (TTF) | MZL: Umbralisib | 13.1 | 95% Confidence Interval 1.4 to NA | months | |
| Time to Treatment Failure (TTF) | WM: Umbralisib | 6.5 | 95% Confidence Interval 2.1 to 15.9 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Marginal Zone Lymphoma (MZL): Umbralisib | 8 | |
| Overall Study | STARTED | Waldenstrom's Macroglobulinemia (WM): Umbralisib | 13 | |
| Overall Study | Safety Population | Marginal Zone Lymphoma (MZL): Umbralisib | 8 | |
| Overall Study | Safety Population | Waldenstrom's Macroglobulinemia (WM): Umbralisib | 13 | |
| Overall Study | Modified Intent-To-Treat (mITT) | Marginal Zone Lymphoma (MZL): Umbralisib | 8 | |
| Overall Study | Modified Intent-To-Treat (mITT) | Waldenstrom's Macroglobulinemia (WM): Umbralisib | 10 | |
| Overall Study | COMPLETED | Marginal Zone Lymphoma (MZL): Umbralisib | 0 | |
| Overall Study | COMPLETED | Waldenstrom's Macroglobulinemia (WM): Umbralisib | 0 | |
| Overall Study | NOT COMPLETED | Marginal Zone Lymphoma (MZL): Umbralisib | 8 | |
| Overall Study | NOT COMPLETED | Waldenstrom's Macroglobulinemia (WM): Umbralisib | 13 |
Source ClinicalTrials.gov
Adverse events220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | MZL: Umbralisib | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | WM: Umbralisib | 4 | 13 | |
| other | Neutropenia | Blood and lymphatic system disorders | MZL: Umbralisib | 0 | 8 | |
| other | Neutropenia | Blood and lymphatic system disorders | WM: Umbralisib | 3 | 13 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MZL: Umbralisib | 0 | 8 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | WM: Umbralisib | 2 | 13 | |
| other | Leukocytosis | Blood and lymphatic system disorders | MZL: Umbralisib | 0 | 8 | |
| other | Leukocytosis | Blood and lymphatic system disorders | WM: Umbralisib | 1 | 13 | |
| other | Atrial fibrillation | Cardiac disorders | MZL: Umbralisib | 0 | 8 | |
| other | Atrial fibrillation | Cardiac disorders | WM: Umbralisib | 1 | 13 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MZL: Umbralisib | 1 | 8 |
| Total, all-cause mortality | WM: Umbralisib | 0 | 13 |
| Total, other adverse events | MZL: Umbralisib | 8 | 8 |
| Total, other adverse events | WM: Umbralisib | 13 | 13 |
| Total, serious adverse events | MZL: Umbralisib | 1 | 8 |
| Total, serious adverse events | WM: Umbralisib | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MZL: Umbralisib vs WM: Umbralisib: Number of Participants With at Least One Adverse Event (AE) | Trial comparisons |
| MZL: Umbralisib vs WM: Umbralisib: deaths from any cause | Trial comparisons |
| MZL: Umbralisib vs WM: Umbralisib: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03364231
GET https://conductscience.org/api/trials/v1/NCT03364231/events?page=2