Trial · NCT03801525
Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)
NCT03801525, Phase 2, Phase 3, Terminated, TG Therapeutics, Inc.; results first posted 2024-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V). Trials, record NCT03801525. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03801525
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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 Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)
- NCT number
- NCT03801525
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 277 participants, actual
- Lead sponsor
- TG Therapeutics, Inc.
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Interventions
- Ublituximab, Umbralisib, Venetoclax
- First posted
- 2019-01-11
- Last updated
- 2024-04-19
- Results first posted
- 2024-04-19
- Limitations and caveats
Due to sponsor's business decision, the clinical trial was terminated by the sponsor prematurely. As such, the study results are reflective of the data captured to the time of study termination and with limited data verification.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Criteria | Up to 43.2 months | CR rate=percent of participants who achieved CR or complete response with incomplete marrow recovery(CRi).CR=no evidence of new disease,absolute lymphocyte count(ALC) in peripheral blood\<4x10\^9 per liter(/L),regression of nodal masses to normal size \<1.5 centimeters(cm) in longest diameter(LD),normal spleen and liver size,no constitutional symptoms,cytological/pathological evaluation of bone marrow(BM) smear/biopsy must be at least normocellular for age without evidence for typical chronic lymphocytic leukemia(CLL)/small lymphocytic lymphoma(SLL) lymphocytes by morphological criteria,peripheral blood counts with absolute neutrophil count(ANC)≥1.5x10\^9/L or platelet≥100x10\^9/L or hemoglobin≥110 grams per liter(g/L) without red blood cell(RBC) transfusions,all without need for exogenous growth factors.CRi=all CR criteria but with persistent anemia,thrombocytopenia,or neutropenia or hypocellular BM that is related to prior/ongoing drug toxicity(and not to CLL/SLL). |
| Primary | Phase 2: Overall Response Rate (ORR) Per iwCLL 2018 Criteria | Up to 43.2 months | ORR=percent of participants who achieve CR,CRi,partial response(PR) or PR with lymphocytosis(PR-L).CR=no evidence of new disease;ALC\<4x10\^9/L;regression of nodal masses to\<1.5cm LD;normal spleen,liver size;no constitutional symptoms;cytological/pathological evaluation of BM smear/biopsy must be at least normocellular for age;ANC≥1.5x10\^9/L,platelet≥100x10\^9/L,Hb≥110g/L.CRi=CR criteria but with persistent anemia,thrombocytopenia,or neutropenia/hypocellular BM related to prior/ongoing drug toxicity.PR=no evidence of new disease,meets≥2 criteria:≥50% decrease from baseline(BL) in ALC(or decrease to\<4x10\^9/L) or sum of products(SPD) of target nodal lesions or CLL/SLL marrow infiltrate/Blymphoid;no target,splenic,liver,or non-target disease with worsening that meets criteria for definitive progressive disease(PD);platelet\>100x10\^9/L or Hb≥110g/L or ≥50% increase from BL in each.PR-L=PR criteria but not had ≥50% decrease from BL in ALC/decrease to\<4x10\^9/L. |
| Primary | Phase 3: Progression-Free Survival (PFS) Per iwCLL 2018 Criteria | Up to 43.2 months | PFS was assessed in participants treated with U2-V compared with U2. PFS was defined as the interval between randomization and the date of definitive PD (as confirmed by the IRC) or death due to any cause, whichever occurs first. Participants who had no event (progression or death) were censored at the day of their last adequate disease assessment. PD= appearance of new nodes \>1.5 cm in the LD, \>50% increase in greatest diameter, new or recurrent hepatomegaly or splenomegaly, new unequivocal extra-nodal lesion, new non-target disease, ≥50% increase from the nadir in the sum of products of diameters (SPD) of target lesions, ≥50% increase in the LD of an individual node or extra-nodal mass, splenic/hepatic enlargement of ≥50% from nadir, unequivocal increase in the size of non-target disease, transformation to a more aggressive histology, decrease in platelet count or Hgb, \>50% decrease from the highest on-study platelet count, \>20 g/L decrease from the highest on-study Hgb. |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | Up to 43.2 months | The MRD negativity rate was defined as the percentage of participants who achieved MRD negative status post-baseline, defined as a quantitative detection of less than one CLL/SLL cell in 10000 leukocytes by flow cytometry (MRD level, 10\^-4) in blood or bone marrow (BM). If a participant was determined to be MRD negative by peripheral blood, a bone marrow aspirate was obtained to assess MRD in the bone marrow. Participants who did not have an MRD assessment at any post-baseline visits were considered non-responders and were included in the denominator when calculating MRD negativity rate. |
| Secondary | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Up to 43.2 months | An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have to have a causal relationship with this 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. TEAE is any AE that occur after first dosing of study medication and through the end of the study or through 30 days after the last dose of study treatment, or is considered treatment-related regardless of the start date of the event, or is present before first dosing of study medication but worsens in intensity or the investigator subsequently considers treatment-related. |
| Secondary | Phase 2: Time to Response (TTR) Per iwCLL 2018 Criteria | Up to 43.2 months | TTR was defined as the interval from enrollment to first documentation of CR, CRi, PR, or PR-L. TTR was analyzed via Kaplan-Meier method. CR=no evidence of new disease; ALC\<4x10\^9/L; regression of nodal masses to \<1.5cm LD; normal spleen ,liver size; no constitutional symptoms; cytological/pathological evaluation of BM smear/biopsy must be at least normocellular for age; ANC≥1.5x10\^9/L, platelet≥100x10\^9/L, Hb≥110g/L. CRi=CR criteria but with persistent anemia, thrombocytopenia, or neutropenia/hypocellular BM related to prior/ongoing drug toxicity.PR=no evidence of new disease,meets≥2 criteria:≥50% decrease from BL in ALC (or decrease to\<4x10\^9/L) or SPD of target nodal lesions or CLL/SLL marrow infiltrate/B-lymphoid; no target, splenic, liver, or non-target disease with worsening that meets criteria for definitive PD; platelet\>100x10\^9/L or Hb≥110g/L or ≥50% increase from BL in each.PR-L=PR criteria but not had ≥50% decrease from BL in ALC/decrease to\<4x10\^9/L. |
| Secondary | Phase 2: Duration of Response (DOR) Per iwCLL 2018 Criteria | Up to 43.2 months | DOR=interval from 1st documentation of CR,CRi,PR or PR-L to earlier of 1st documentation of definitive PD or death from any cause.CR=no evidence of new disease;ALC\<4x10\^9/L;regression of nodal masses to\<1.5cm LD;normal spleen,liver size;no constitutional symptoms;cytological/pathological evaluation of BM smear/biopsy must be at least normocellular for age;ANC≥1.5x10\^9/L,platelet≥100x10\^9/L,Hb≥110g/L.CRi=CR criteria but with persistent anemia,thrombocytopenia,neutropenia/hypocellular BM related to prior/ongoing drug toxicity.PR=no evidence of new disease,meets≥2 criteria:≥50% decrease from BL in ALC(or decrease to\<4x10\^9/L) or SPD of target nodal lesions or CLL/SLL marrow infiltrate/Blymphoid;no target,splenic,liver,or non-target disease with worsening that meets criteria for definitive PD;platelet\>100x10\^9/L or Hb≥110g/L or ≥50% increase from BL in each.PR-L=PR criteria;not≥50% decrease from BL in ALC/decrease to\<4x10\^9/L.PD=evidence of new disease per protocol-specififed criteria. |
| Secondary | Phase 3: CR Rate as Assessed by an Independent Review Committee (IRC) Per iwCLL 2018 Criteria | Up to 43.2 months | CR rate=percent of participants who achieved CR or CRi. CR=no evidence of new disease; ALC\<4x10\^9/L; regression of nodal masses to \<1.5 cm LD; normal spleen, liver size; no constitutional symptoms; cytological/pathological evaluation of BM smear/biopsy must be at least normocellular for age; ANC ≥1.5x10\^9/L, platelet ≥100x10\^9/L, Hb ≥110g/L. CRi=CR criteria but with persistent anemia,thrombocytopenia,or neutropenia/hypocellular BM related to prior/ongoing drug toxicity. CR assessment was subject to independent confirmation by the IRC in participants enrolled to the Phase 3 stage of the study. |
| Secondary | Phase 3: ORR as Assessed by IRC Per iwCLL 2018 Criteria | Up to 43.2 months | ORR=percent of participants who achieve CR, CRi, PR or PR-L.CR=no evidence of new disease; ALC\<4x10\^9/L; regression of nodal masses to\<1.5cm LD; normal spleen and liver size; no constitutional symptoms; cytological/pathological evaluation of BM smear/biopsy must be at least normocellular for age; ANC≥1.5x10\^9/L, platelet≥100x10\^9/L, Hb≥110g/L. CRi=CR criteria but with persistent anemia, thrombocytopenia, or neutropenia/hypocellular BM related to prior/ongoing drug toxicity.PR=no evidence of new disease,meets≥2 criteria:≥50% decrease from baseline (BL) in ALC (or decrease to\<4x10\^9/L) or SPD of target nodal lesions or CLL/SLL marrow infiltrate/B-lymphoid; no target, splenic, liver, or non-target disease with worsening that meets criteria for definitive PD; platelet\>100x10\^9/L or Hb≥110g/L or ≥50% increase from BL in each.PR-L=PR criteria but not had ≥50% decrease from BL in ALC/decrease to\<4x10\^9/L. |
| Secondary | Phase 3: Overall Survival (OS) | Up to 43.2 months | Overall Survival (OS) was defined as the interval from randomization to death from any cause. OS data was censored at the last documented date that the participant was confirmed alive for participants who withdrew consent or were lost to follow-up prior to the end of the study, and for participants whose vital status in the study could not be determined. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Criteria | Up to 43.2 months | ITT population for Phase 2 consisted of all participants who received at least one dose of each study drug (ublituximab, umbralisib, and venetoclax). Percentages were rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| PRIMARY | Phase 2: Overall Response Rate (ORR) Per iwCLL 2018 Criteria | Up to 43.2 months | ITT population for Phase 2 consisted of all participants who received at least one dose of each study drug (ublituximab, umbralisib, and venetoclax). Percentages were rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| PRIMARY | Phase 3: Progression-Free Survival (PFS) Per iwCLL 2018 Criteria | Up to 43.2 months | ITT population for Phase 3 consisted of all participants who were randomized. Percentages were rounded off to the nearest decimal point. | months | MEDIAN |
| SECONDARY | Minimal Residual Disease (MRD) Negativity Rate | Up to 43.2 months | In Phase 2, ITT population consisted of all participants who received at least one dose of each study drug (ublituximab, umbralisib, and venetoclax); and in Phase 3, ITT population consisted of all participants who were randomized. Percentages were rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Up to 43.2 months | Safety population consisted of all participants who received at least one dose of any study drug (ublituximab, umbralisib, and venetoclax). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 2: Time to Response (TTR) Per iwCLL 2018 Criteria | Up to 43.2 months | ITT population for Phase 2 consisted of all participants who received at least one dose of each study drug (ublituximab, umbralisib, and venetoclax). Only responders i.e., participants with ORR were assessed for this outcome measure. | months | MEDIAN |
| SECONDARY | Phase 2: Duration of Response (DOR) Per iwCLL 2018 Criteria | Up to 43.2 months | ITT population for Phase 2 consisted of all participants who received at least one dose of each study drug (ublituximab, umbralisib, and venetoclax). Only responders i.e., participants with ORR were assessed for this outcome measure. | months | MEDIAN |
| SECONDARY | Phase 3: CR Rate as Assessed by an Independent Review Committee (IRC) Per iwCLL 2018 Criteria | Up to 43.2 months | ITT population for Phase 3 consisted of all participants who were randomized. Percentages were rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Phase 3: ORR as Assessed by IRC Per iwCLL 2018 Criteria | Up to 43.2 months | ITT population for Phase 3 consisted of all participants who were randomized. Percentages were rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Phase 3: Overall Survival (OS) | Up to 43.2 months | ITT population for Phase 3 consisted of all participants who were randomized. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 2: Complete Response (CR) Rate as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Criteria | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 33.6 | percentage of participants | ||
| Phase 2: Overall Response Rate (ORR) Per iwCLL 2018 Criteria | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 93.3 | percentage of participants | ||
| Phase 3: Progression-Free Survival (PFS) Per iwCLL 2018 Criteria | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | NA | Full Range 0.0 to 15.7 | months | |
| Phase 3: Progression-Free Survival (PFS) Per iwCLL 2018 Criteria | Phase 3: Ublituximab + Umbralisib (U2) | NA | Full Range 0.0 to 13.1 | months | |
| Minimal Residual Disease (MRD) Negativity Rate | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 94.0 | 95% Confidence Interval 88.8 to 97.2 | percentage of participants | |
| Minimal Residual Disease (MRD) Negativity Rate | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 50.0 | 95% Confidence Interval 36.3 to 63.7 | percentage of participants | |
| Minimal Residual Disease (MRD) Negativity Rate | Phase 3: Ublituximab + Umbralisib (U2) | 19.6 | 95% Confidence Interval 10.2 to 32.4 | percentage of participants | |
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 165 | Participants | ||
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 56 | Participants | ||
| Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | Phase 3: Ublituximab + Umbralisib (U2) | 51 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 165 | |
| Overall Study | STARTED | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 56 | |
| Overall Study | STARTED | Phase 3: Ublituximab + Umbralisib (U2) | 56 | |
| Overall Study | Intent-To-Treat (ITT) Population | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 149 | |
| Overall Study | Intent-To-Treat (ITT) Population | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 56 | |
| Overall Study | Intent-To-Treat (ITT) Population | Phase 3: Ublituximab + Umbralisib (U2) | 56 | |
| Overall Study | COMPLETED | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 11 | |
| Overall Study | COMPLETED | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 0 | |
| Overall Study | COMPLETED | Phase 3: Ublituximab + Umbralisib (U2) | 0 | |
| Overall Study | NOT COMPLETED | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 154 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events531
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 | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 36 | 165 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 5 | 56 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 3: Ublituximab + Umbralisib (U2) | 4 | 53 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 31 | 165 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 11 | 56 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 3: Ublituximab + Umbralisib (U2) | 5 | 53 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 11 | 165 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 1 | 56 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Phase 3: Ublituximab + Umbralisib (U2) | 1 | 53 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 7 | 165 |
1 to 10 of 531Source ClinicalTrials.gov
See all 531 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 32 | 165 |
| Total, all-cause mortality | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 1 | 56 |
| Total, all-cause mortality | Phase 3: Ublituximab + Umbralisib (U2) | 5 | 56 |
| Total, other adverse events | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 165 | 165 |
| Total, other adverse events | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 56 | 56 |
| Total, other adverse events | Phase 3: Ublituximab + Umbralisib (U2) | 49 | 53 |
| Total, serious adverse events | Phase 2: Ublituximab + Umbralisib + Venetoclax (U2-V) | 84 | 165 |
| Total, serious adverse events | Phase 3: Ublituximab + Umbralisib + Venetoclax (U2-V) | 12 | 56 |
| Total, serious adverse events | Phase 3: Ublituximab + Umbralisib (U2) | 16 | 53 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03801525
GET https://conductscience.org/api/trials/v1/NCT03801525/events?page=2