Trial · NCT05144009
A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)
NCT05144009, Phase 2, Terminated, ADC Therapeutics S.A.; results first posted 2025-01-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL). Trials, record NCT05144009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05144009
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)
- NCT number
- NCT05144009
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- ADC Therapeutics S.A.
- Conditions
- Diffuse Large B-cell Lymphoma
- Interventions
- Loncastuximab Tesirine, Rituximab
- First posted
- 2021-12-03
- Last updated
- 2025-01-30
- Other registries' IDs
- eudract:2021-005312-57
- Results first posted
- 2025-01-30
- Limitations and caveats
Due to the early termination of the study, the objectives of the study could not be fully assessed (e.g. overall survival). The median duration of follow-up for all participants was limited because of early termination of the study.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CR Rate | Up to a maximum of 17.1 months | Defined as percentage of participants with a best overall response (BOR) of CR as determined by the Investigator according to the 2014 Lugano Classification criteria. CR was defined as achieving: * Complete metabolic response for positron emission tomography (PET)-computed tomography (CT) OR * Complete radiologic response (target node regress to \<1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology) for CT if disease was not fluorodeoxyglucose (FDG)-avid at baseline. |
| Primary | Cohort B: Percentage of Participants Who Completed 4 Cycles of Treatment | Up to 12 weeks (3 week cycle length) | Defined by the number of participants who completed a total of 4 cycles of therapy divided by the total number of participants \* 100. |
| Secondary | Overall Response Rate (ORR) | Up to a maximum of 17.1 months | Defined as the percentage of participants who achieved either CR or PR as BOR as determined by Investigator according to the 2014 Lugano Classification criteria. CR was defined as achieving: * Complete metabolic response for PET-CT OR * Complete radiologic response (target node regress to \<1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology) for CT if disease was not FDG-avid at baseline. PR was defined as achieving: * Partial metabolic response (findings indicate residual disease) for PET-CT OR * Partial remission (\>50% decrease in target measurable nodes, regression/ absence/ no increase of non-measured lesions, spleen regressed by \>50% in length and no new lesions) for CT if disease was not FDG-avid at baseline. |
| Secondary | 2-year Progression-free Survival (PFS) | 2 years | PFS was defined as the time from first dose of study drug until the first date of either disease progression (PD) or death due to any cause. The 2-year PFS was defined as the percentage of participants that were PFS event-free at 2 years per investigator assessment with 95% confidence interval (CI) estimated using Kaplan-Meier method. |
| Secondary | 3-year Overall Survival (OS) | 3 years | OS was defined as the time from randomization date until death due to any cause. The 3-year OS was defined as the percentage of participants that were OS event-free at 3 years with 95% CI estimated using Kaplan-Meier method. |
| Secondary | Duration of Response (DoR) | Up to a maximum of 17.1 months | Defined for participants with CR or PR only as the interval between the date of initial documentation of a response and the date of the first documented progressive disease (based on radiographic or clinical progression at end of study or death due to any cause, whichever occurred first) per investigator assessment with 95% CI estimated using Kaplan-Meier method. CR was defined as achieving: * Complete metabolic response for PET-CT OR * Complete radiologic response (target node regress to \<1.5 cm, no non-measured lesions, no organ enlargement, no new lesions and normal bone marrow morphology) for CT if disease was not FDG-avid at baseline. PR was defined as achieving: * Partial metabolic response (findings indicate residual disease) for PET-CT OR * Partial remission (\>50% decrease in target measurable nodes, regression/ absence/ no increase of non-measured lesions, spleen regressed by \>50% in length and no new lesions) for CT if disease was not FDG-avid at baseline. |
| Secondary | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Up to approximately 8 months | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product. A TEAE was defined as an AE that occurred or worsened in the period extending from the first dose of study drug to 15 weeks after the last dose of study drugs in this study or start of a new anticancer therapy, whichever was earlier. A serious AE (SAE) was defined as an AE that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or an important medical event. A severe AE was defined as Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 3 (severe) or above. Clinically significant changes in safety laboratory variables, vital signs, physical examinations, and Eastern Cooperative Oncology Group performance score were recorded as AEs. |
| Secondary | Maximum Observed Concentration (Cmax) of Conjugated Antibody | Cycle 1 Day 2: predose (preferably within 2 h prior to start of infusion) and at the end (within -5 to +10 min) of loncastuximab tesirine infusion; Cycles 2-6 Day 1 predose and at the end of loncastuximab tesirine infusion (3 week cycle length) | Pharmacokinetic (PK) was assessed by a central laboratory using validated bioanalytical methods. Analysis considered model development for conjugated antibodies and total antibodies only, as pre-specified in protocol section 9.9. |
| Secondary | Cmax of Total Antibody | Cycle 1 Day 2: predose (preferably within 2 h prior to start of infusion) and at the end (within -5 to +10 min) of loncastuximab tesirine infusion; Cycles 2-6 Day 1 predose and at the end of loncastuximab tesirine infusion (3 week cycle length) | PK was assessed by a central laboratory using validated bioanalytical methods. Analysis considered model development for conjugated antibodies and total antibodies only, as pre-specified in protocol section 9.9. |
| Secondary | Trough Concentration (Ctrough) of Conjugated Antibody | Cycle 1 Day 2: predose (preferably within 2 h prior to start of infusion); Cycles 2-6 Day 1 predose (3 week cycle length) | PK was assessed by a central laboratory using validated bioanalytical methods. Analysis considered model development for conjugated antibodies and total antibodies only, as pre-specified in protocol section 9.9. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CR Rate | Up to a maximum of 17.1 months | All-Treated Population: All participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Cohort B: Percentage of Participants Who Completed 4 Cycles of Treatment | Up to 12 weeks (3 week cycle length) | All-Treated Population: All participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Up to a maximum of 17.1 months | All-Treated Population: All participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | 2-year Progression-free Survival (PFS) | 2 years | All-Treated Population: All participants who received at least 1 dose of study drug. No data was collected for this endpoint due to study early termination. | ||
| SECONDARY | 3-year Overall Survival (OS) | 3 years | All-Treated Population: All participants who received at least 1 dose of study drug. No data was collected for this endpoint due to study early termination. | ||
| SECONDARY | Duration of Response (DoR) | Up to a maximum of 17.1 months | All-Treated Population: All participants who received at least 1 dose of study drug. Inclusive of participants who were censored. | months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Up to approximately 8 months | All-Treated Population: All participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Concentration (Cmax) of Conjugated Antibody | Cycle 1 Day 2: predose (preferably within 2 h prior to start of infusion) and at the end (within -5 to +10 min) of loncastuximab tesirine infusion; Cycles 2-6 Day 1 predose and at the end of loncastuximab tesirine infusion (3 week cycle length) | PK Population: All participants who received study drug and have at least 1 pre-(Cycle 1 Day 1) and 1 post-dose valid PK assessment. Inclusive of only participants with available data at each timepoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax of Total Antibody | Cycle 1 Day 2: predose (preferably within 2 h prior to start of infusion) and at the end (within -5 to +10 min) of loncastuximab tesirine infusion; Cycles 2-6 Day 1 predose and at the end of loncastuximab tesirine infusion (3 week cycle length) | PK Population: All participants who received study drug and have at least 1 pre-(Cycle 1 Day 1) and 1 post-dose valid PK assessment. Inclusive of only participants with available data at each timepoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Trough Concentration (Ctrough) of Conjugated Antibody | Cycle 1 Day 2: predose (preferably within 2 h prior to start of infusion); Cycles 2-6 Day 1 predose (3 week cycle length) | PK Population: All participants who received study drug and have at least 1 pre-(Cycle 1 Day 1) and 1 post-dose valid PK assessment. Inclusive of only participants with available data at each timepoint. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CR Rate | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 52.9 | 95% Confidence Interval 27.8 to 77.0 | percentage of participants | |
| CR Rate | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 41.7 | 95% Confidence Interval 22.1 to 63.4 | percentage of participants | |
| Cohort B: Percentage of Participants Who Completed 4 Cycles of Treatment | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 33.3 | percentage of participants | ||
| Overall Response Rate (ORR) | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 94.1 | 95% Confidence Interval 71.3 to 99.9 | percentage of participants | |
| Overall Response Rate (ORR) | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 66.7 | 95% Confidence Interval 44.7 to 84.4 | percentage of participants | |
| Duration of Response (DoR) | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 5.49 | 95% Confidence Interval 2.27 to NA | months | |
| Duration of Response (DoR) | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | NA | 95% Confidence Interval NA to NA | months | |
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | Any TEAEs | 17 | Participants | |
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | Any TEAEs | 23 | Participants | |
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | Any CTCAE Grade 3 or Higher TEAEs | 13 | Participants |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 17 | |
| Overall Study | STARTED | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 24 | |
| Overall Study | COMPLETED | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 0 | |
| Overall Study | COMPLETED | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 0 | |
| Overall Study | NOT COMPLETED | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 17 | |
| Overall Study | NOT COMPLETED | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 24 |
Source ClinicalTrials.gov
Adverse events294
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 | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 2 | 17 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 3 | 24 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 2 | 17 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 2 | 24 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 3 | 17 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 1 | 24 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 2 | 17 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 1 | 24 | 1 |
| other | Pericardial effusion | Cardiac disorders | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 5 | 17 | 6 |
| other | Pericardial effusion | Cardiac disorders | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 2 | 24 | 2 |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 5 | 17 |
| Total, all-cause mortality | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 10 | 24 |
| Total, other adverse events | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 17 | 17 |
| Total, other adverse events | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 22 | 24 |
| Total, serious adverse events | Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) | 13 | 17 |
| Total, serious adverse events | Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R) | 16 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42879743 | DERIVED |
Source PubMed
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 |
|---|---|
| Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) vs Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R): Number of Participants With Confirmed Positive Anti-Drug Antibody (ADA) Response | Trial comparisons |
| Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) vs Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R): deaths from any cause | Trial comparisons |
| Cohort A: Loncastuximab Tesirine + Rituximab (Lonca-R) vs Cohort B: Loncastuximab Tesirine + Rituximab (Lonca-R): 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/NCT05144009
GET https://conductscience.org/api/trials/v1/NCT05144009/results?page=2