Trial · NCT04390113
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
NCT04390113, Phase 3, Terminated, AlloVir; results first posted 2024-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC). Trials, record NCT04390113. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04390113
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
- NCT number
- NCT04390113
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 97 participants, actual
- Lead sponsor
- AlloVir
- Conditions
- BK Virus Infection, Hemorrhagic Cystitis
- Interventions
- Posoleucel (ALVR105), Placebo
- First posted
- 2020-05-15
- Last updated
- 2024-05-14
- Results first posted
- 2024-05-14
- Limitations and caveats
AlloVir decided to discontinue the trial on 22-Dec-2023 following a pre-planned DSMB futility analysis concluding 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 | Time to Resolution of Macroscopic Hematuria | Up to 24 weeks | Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study. |
| Secondary | Time Until Bladder Pain is Resolved | Until event occurrence through Week 24 | |
| Secondary | Days in the Hospital for Any Reason | Until event occurrence through Week 24 | |
| Secondary | Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD) | Up to 24 weeks | Grading of acute GVHD is reported according to CTCAE version 5.0 which ranges from Grade 0 (best/no disease) to Grade IV (worst). Participants with Grade I-IV are included. |
| Secondary | Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS) | Up to 24 weeks | CRS is defined as a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms can be progressive, must include fever at the onset, and may include hypotension, capillary leak (hypoxia), and end organ dysfunction. |
| Secondary | Time to Resolution for All Target Viruses | Until event occurrence through Week 24 | |
| Secondary | Average Daily Bladder Pain | Until event occurrence through Week 6 |
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 | Time to Resolution of Macroscopic Hematuria | Up to 24 weeks | BK Intent-to-Treat \[ITT\] Population: All patients randomized who had BKV in their urine at baseline. | Days | MEDIAN |
| SECONDARY | Time Until Bladder Pain is Resolved | Until event occurrence through Week 24 | 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 | Days in the Hospital for Any Reason | Until event occurrence through Week 24 | 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 Treatment Emergent Acute Graft Versus Host Disease (GVHD) | Up to 24 weeks | Modified ITT Population (mITT): All randomized participants who receive any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS) | Up to 24 weeks | mITT: All randomized participants who receive any dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Resolution for All Target Viruses | Until event occurrence through Week 24 | Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint. | ||
| SECONDARY | Average Daily Bladder Pain | Until event occurrence through Week 6 | 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 group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Resolution of Macroscopic Hematuria | Posoleucel (ALVR105) | 36 | 95% Confidence Interval 22.0 to 63.0 | Days | |
| Time to Resolution of Macroscopic Hematuria | Placebo | 31 | 95% Confidence Interval 18.0 to 63.0 | Days | |
| Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD) | Posoleucel (ALVR105) | 11 | Participants | ||
| Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD) | Placebo | 9 | Participants | ||
| Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS) | Posoleucel (ALVR105) | 1 | Participants | ||
| Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS) | Placebo | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Posoleucel (ALVR105) | 57 | |
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | COMPLETED | Posoleucel (ALVR105) | 37 | |
| Overall Study | COMPLETED | Placebo | 26 | |
| Overall Study | NOT COMPLETED | Posoleucel (ALVR105) | 20 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events318
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 | Pneumonia | Infections and infestations | Posoleucel (ALVR105) | 6 | 57 | |
| other | Pneumonia | Infections and infestations | Placebo | 4 | 39 | |
| other | COVID-19 | Infections and infestations | Posoleucel (ALVR105) | 6 | 57 | |
| other | COVID-19 | Infections and infestations | Placebo | 3 | 39 | |
| other | Urinary tract infection | Infections and infestations | Posoleucel (ALVR105) | 3 | 57 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 5 | 39 | |
| other | Cytomegalovirus infection reactivation | Infections and infestations | Posoleucel (ALVR105) | 3 | 57 | |
| other | Cytomegalovirus infection reactivation | Infections and infestations | Placebo | 3 | 39 | |
| other | Oral candidiasis | Infections and infestations | Posoleucel (ALVR105) | 3 | 57 | |
| other | Oral candidiasis | Infections and infestations | Placebo | 3 | 39 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Posoleucel (ALVR105) | 2 | 57 |
| Total, all-cause mortality | Placebo | 1 | 40 |
| Total, other adverse events | Posoleucel (ALVR105) | 54 | 57 |
| Total, other adverse events | Placebo | 36 | 39 |
| Total, serious adverse events | Posoleucel (ALVR105) | 28 | 57 |
| Total, serious adverse events | Placebo | 19 | 39 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Posoleucel (ALVR105) vs Placebo: Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD) | Trial comparisons |
| Posoleucel (ALVR105) vs Placebo: Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS) | Trial comparisons |
| Posoleucel (ALVR105) vs Placebo: deaths from any cause | Trial comparisons |
| Posoleucel (ALVR105) vs Placebo: 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/NCT04390113
GET https://conductscience.org/api/trials/v1/NCT04390113/events?page=2