Trial · NCT05179057
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
NCT05179057, Phase 3, Terminated, AlloVir; results first posted 2024-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation. Trials, record NCT05179057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05179057
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
- NCT number
- NCT05179057
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- AlloVir
- Conditions
- Adenovirus Infection
- Interventions
- Posoleucel, Placebo
- First posted
- 2022-01-05
- Last updated
- 2024-05-08
- Results first posted
- 2024-05-08
- Limitations and caveats
- The study was discontinued following a pre-planned DSMB futility analysis concluding that the study was unlikely to meet its primary endpoint, no safety concerns were identified.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Undetectable Adenovirus Infection | Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion) | Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ). |
| Primary | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to 34 weeks | A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator. |
| Secondary | Number of Participants With Overall Disease Progression | From Day 29 up to Week 10 | |
| Secondary | Area Under the Curve (AUC) Adenovirus Viral Load | Pre-dose and Day 29 | |
| Secondary | Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29 | Day 29 | |
| Secondary | Time to Undetectable Adenovirus Viremia (Less Than LLOQ) | Pre-dose to 34 weeks | |
| Secondary | Number of Participants With Adenovirus Disease Recurrence | 34 weeks |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Undetectable Adenovirus Infection | Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion) | The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of posoleucel or placebo. Only participants in the mITT population who completed through Day 29 or discontinued early were included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to 34 weeks | The safety population included all participants who received any amount of posoleucel or placebo and had at least one post-treatment safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Disease Progression | From Day 29 up to Week 10 | Data not collected due to early termination after Data and Safety Monitoring Board (DSMB) futility analysis concluded the study was unlikely to meet its primary endpoint. | ||
| SECONDARY | Area Under the Curve (AUC) Adenovirus Viral Load | Pre-dose and Day 29 | Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint. | ||
| SECONDARY | Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29 | Day 29 | Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint. | ||
| SECONDARY | Time to Undetectable Adenovirus Viremia (Less Than LLOQ) | Pre-dose to 34 weeks | Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint. | ||
| SECONDARY | Number of Participants With Adenovirus Disease Recurrence | 34 weeks | Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint. |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Undetectable Adenovirus Infection | Posoleucel, Then Placebo | 11 | Participants | ||
| Number of Participants With Undetectable Adenovirus Infection | Placebo, Then Posoleucel | 9 | Participants | ||
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Posoleucel (Primary Study Period) | Any TEAE | 27 | Participants | |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Placebo (Primary Study Period) | Any TEAE | 23 | Participants | |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Posoleucel (Cross-over Period) | Any TEAE | 5 | Participants | |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Placebo (Cross-over Period) | Any TEAE | 3 | Participants | |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Posoleucel (Primary Study Period) | Any TEAE related to study treatment | 7 | Participants | |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Placebo (Primary Study Period) | Any TEAE related to study treatment | 9 | Participants | |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Posoleucel (Cross-over Period) | Any TEAE related to study treatment | 1 | Participants | |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Placebo (Cross-over Period) | Any TEAE related to study treatment | 1 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Posoleucel, Then Placebo | 30 | |
| Overall Study | STARTED | Placebo, Then Posoleucel | 27 | |
| Overall Study | Received Primary Study Treatment | Posoleucel, Then Placebo | 28 | |
| Overall Study | Received Primary Study Treatment | Placebo, Then Posoleucel | 23 | |
| Overall Study | Met Cross-over Eligibility Criteria | Posoleucel, Then Placebo | 4 | |
| Overall Study | Met Cross-over Eligibility Criteria | Placebo, Then Posoleucel | 5 | |
| Overall Study | Received Cross-over Treatment | Posoleucel, Then Placebo | 4 | |
| Overall Study | Received Cross-over Treatment | Placebo, Then Posoleucel | 5 | |
| Overall Study | COMPLETED | Posoleucel, Then Placebo | 10 | |
| Overall Study | COMPLETED | Placebo, Then Posoleucel | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events632
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 | COVID-19 | Infections and infestations | Posoleucel (Primary Study Period) | 3 | 28 | |
| other | COVID-19 | Infections and infestations | Placebo (Primary Study Period) | 1 | 23 | |
| other | COVID-19 | Infections and infestations | Posoleucel (Cross-over Period) | 0 | 5 | |
| other | COVID-19 | Infections and infestations | Placebo (Cross-over Period) | 1 | 4 | |
| other | Rhinovirus infection | Infections and infestations | Posoleucel (Primary Study Period) | 2 | 28 | |
| other | Rhinovirus infection | Infections and infestations | Placebo (Primary Study Period) | 3 | 23 | |
| other | Rhinovirus infection | Infections and infestations | Posoleucel (Cross-over Period) | 0 | 5 | |
| other | Rhinovirus infection | Infections and infestations | Placebo (Cross-over Period) | 0 | 4 | |
| other | BK virus infection | Infections and infestations | Posoleucel (Primary Study Period) | 3 | 28 | |
| other | BK virus infection | Infections and infestations | Placebo (Primary Study Period) | 1 | 23 |
1 to 10 of 632Source ClinicalTrials.gov
See all 632 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Posoleucel (Primary Study Period) | 2 | 28 |
| Total, all-cause mortality | Placebo (Primary Study Period) | 1 | 23 |
| Total, all-cause mortality | Posoleucel (Cross-over Period) | 0 | 5 |
| Total, all-cause mortality | Placebo (Cross-over Period) | 1 | 4 |
| Total, other adverse events | Posoleucel (Primary Study Period) | 27 | 28 |
| Total, other adverse events | Placebo (Primary Study Period) | 23 | 23 |
| Total, other adverse events | Posoleucel (Cross-over Period) | 5 | 5 |
| Total, other adverse events | Placebo (Cross-over Period) | 3 | 4 |
| Total, serious adverse events | Posoleucel (Primary Study Period) | 16 | 28 |
| Total, serious adverse events | Placebo (Primary Study Period) | 16 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38597860 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Posoleucel, Then Placebo vs Placebo, Then Posoleucel: Number of Participants With Undetectable Adenovirus Infection |
Source 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/NCT05179057
GET https://conductscience.org/api/trials/v1/NCT05179057/results?page=2