Trial · NCT02612311
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
NCT02612311, Phase 3, Terminated, TG Therapeutics, Inc.; results first posted 2024-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia. Trials, record NCT02612311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02612311
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
- NCT number
- NCT02612311
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 603 participants, actual
- Lead sponsor
- TG Therapeutics, Inc.
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Obinutuzumab, Ublituximab, TGR-1202, Chlorambucil
- First posted
- 2015-11-23
- Last updated
- 2024-12-13
- Other registries' IDs
- eudract:2015-005758-36
- Results first posted
- 2024-05-07
- 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 outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria | From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months) | PFS was defined as the interval from enrollment to the earlier of the first documentation of definitive disease progression (PD) or death from any cause. PD was appearance of new nodes \>1.5 centimetres (cm) in the longest diameter (LD) and \>1.0 in longest perpendicular diameter (LPD), new or recurrent hepatomegaly or splenomegaly, new or reappearance of an unequivocal extra-nodal lesion, ≥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 grams per Liter (g/L) decrease from the highest on-study hemoglobin (Hgb). |
| Secondary | Overall Response Rate (ORR) Per iwCLL Criteria | Up to 87 months | ORR=percent of participants who achieve complete response (CR), complete response with incomplete marrow recovery (CRi), partial response (PR) or nodular partial response (nPR).CR: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/liter(L);Regression of all target nodal masses to ≤1.5cm in LD;Normal spleen,liver size;Regression to normal of all nodal non-target disease and disappearance of all detectable;Non-nodal,non-target disease;Morphologically negative bone marrow;No lymphoid nodules;ANC \>1.5x10\^9/L,platelets≥100x10\^9/L,Hgb≥110 g/L.PR:No evidence of new disease; Response in 2 of following if abnormal at baseline: ALC\<4x10\^9/L or ≥50% decrease from baseline in sum of products of target nodal lesions;splenomegaly; hepatomegaly;≥50% decrease from baseline in CLL marrow infiltrate/B-lymphoid nodules;response in any 1: ANC\>1.5x10\^9/L, platelets\>100x10\^9/L,Hgb\>110g/L or ≥50% increase over baseline in any of these.CRi:for CR except with ANC\<1000/µL and/or platelets\<100. |
| Secondary | Complete Response (CR) Rate | Up to 87 months | The CR rate is defined as the percentage of participants with a best overall response of complete response (CR) or complete response with incomplete marrow recovery (CRi). CR: No evidence of new disease; Absolute lymphocyte count(ALC)\<4x10\^9/L; Regression of all target nodal masses to ≤1.5 cm in LD; Normal spleen,liver size; Regression to normal of all nodal non-target disease and disappearance of all detectable; Non-nodal, non-target disease; Morphologically negative bone marrow; No lymphoid nodules; ANC\>1.5x10\^9/L,platelets≥100x10\^9/L,hemoglobin (Hgb)≥110 g/L. CRi was as for CR except with ANC \<1000/µL and/or platelets \<100,000/µL. |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate | From Cycle 6 until Cycle 15 (cycle length=28 days) up to approximately 81.5 months | MRD negativity rate is defined as the percentage of participants who are MRD negative. 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. |
| Secondary | Duration of Response (DOR) | From first documentation of response to study treatment till disease progression/death (up to approximately 87 months) | DOR is defined as the interval from the first documentation of CR, CRi, PR, or nPR to the earlier of the first documentation of definitive disease progression or death from any cause. |
| Secondary | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose of study treatment up to end of study (up to approximately 87 months) | An adverse event (AE) is any untoward medical occurrence in a participant or 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. |
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 | Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria | From enrolment to the earlier of the first documentation of definitive disease progression (PD) or death (Up to 87 months) | The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Per iwCLL Criteria | Up to 87 months | The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Percentages are rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Complete Response (CR) Rate | Up to 87 months | The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Percentages are rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Minimal Residual Disease (MRD) Negativity Rate | From Cycle 6 until Cycle 15 (cycle length=28 days) up to approximately 81.5 months | The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Percentages are rounded off to the nearest decimal point. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | From first documentation of response to study treatment till disease progression/death (up to approximately 87 months) | The ITT population included all randomized participants, regardless of administration of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202). Overall Number of Participants Analyzed is the number of participants with data available for analysis. | months | MEDIAN |
| SECONDARY | Number of Participants Experiencing at Least One Treatment-Emergent Adverse Event (TEAE) | From first dose of study treatment up to end of study (up to approximately 87 months) | The safety population included all randomized participants who had received at least one dose of study treatment (ublituximab, TGR-1202, obinutuzumab + chlorambucil, or ublituximab + TGR-1202 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria | Experimental: Arm A: Ublituximab + Umbralisib | 33.2 | 95% Confidence Interval 27.7 to 39.6 | Months | |
| Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 17.5 | 95% Confidence Interval 16.6 to 22.6 | Months | |
| Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria | Experimental: Arm C: Ublituximab | 32.9 | 95% Confidence Interval 19.1 to 45.0 | Months | |
| Progression-Free Survival (PFS) Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria | Experimental: Arm D: Umbralisib | 22.4 | 95% Confidence Interval 17.2 to 34.7 | Months | |
| Overall Response Rate (ORR) Per iwCLL Criteria | Experimental: Arm A: Ublituximab + Umbralisib | 83.3 | percentage of participants | ||
| Overall Response Rate (ORR) Per iwCLL Criteria | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 68.7 | percentage of participants | ||
| Overall Response Rate (ORR) Per iwCLL Criteria | Experimental: Arm C: Ublituximab | 42.9 | percentage of participants | ||
| Overall Response Rate (ORR) Per iwCLL Criteria | Experimental: Arm D: Umbralisib | 61.5 | percentage of participants | ||
| Complete Response (CR) Rate | Experimental: Arm A: Ublituximab + Umbralisib | 5.7 | percentage of participants | ||
| Complete Response (CR) Rate | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 1.4 | percentage of participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental: Arm A: Ublituximab + Umbralisib | 210 | |
| Overall Study | STARTED | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 211 | |
| Overall Study | STARTED | Experimental: Arm C: Ublituximab | 91 | |
| Overall Study | STARTED | Experimental: Arm D: Umbralisib | 91 | |
| Overall Study | Safety Population | Experimental: Arm A: Ublituximab + Umbralisib | 206 | |
| Overall Study | Safety Population | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 200 | |
| Overall Study | Safety Population | Experimental: Arm C: Ublituximab | 91 | |
| Overall Study | Safety Population | Experimental: Arm D: Umbralisib | 86 | |
| Overall Study | COMPLETED | Experimental: Arm A: Ublituximab + Umbralisib | 0 | |
| Overall Study | COMPLETED | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 0 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,176
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 | Neutropenia | Blood and lymphatic system disorders | Experimental: Arm A: Ublituximab + Umbralisib | 70 | 206 | |
| other | Neutropenia | Blood and lymphatic system disorders | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 79 | 200 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Arm C: Ublituximab | 25 | 91 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental: Arm D: Umbralisib | 15 | 86 | |
| other | Anaemia | Blood and lymphatic system disorders | Experimental: Arm A: Ublituximab + Umbralisib | 29 | 206 | |
| other | Anaemia | Blood and lymphatic system disorders | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 25 | 200 | |
| other | Anaemia | Blood and lymphatic system disorders | Experimental: Arm C: Ublituximab | 15 | 91 | |
| other | Anaemia | Blood and lymphatic system disorders | Experimental: Arm D: Umbralisib | 18 | 86 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Experimental: Arm A: Ublituximab + Umbralisib | 21 | 206 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 44 | 200 |
1 to 10 of 1,176Source ClinicalTrials.gov
See all 1,176 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Arm A: Ublituximab + Umbralisib | 82 | 206 |
| Total, all-cause mortality | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 40 | 200 |
| Total, all-cause mortality | Experimental: Arm C: Ublituximab | 25 | 91 |
| Total, all-cause mortality | Experimental: Arm D: Umbralisib | 29 | 86 |
| Total, other adverse events | Experimental: Arm A: Ublituximab + Umbralisib | 205 | 206 |
| Total, other adverse events | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 189 | 200 |
| Total, other adverse events | Experimental: Arm C: Ublituximab | 84 | 91 |
| Total, other adverse events | Experimental: Arm D: Umbralisib | 84 | 86 |
| Total, serious adverse events | Experimental: Arm A: Ublituximab + Umbralisib | 118 | 206 |
| Total, serious adverse events | Active Comparator: Arm B: Obinutuzumab + Chlorambucil | 47 | 200 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT02612311
GET https://conductscience.org/api/trials/v1/NCT02612311/results?page=2