A Phase 3 interventional study of Posoleucel (ALVR105) and Placebo in BK Virus Infection and Hemorrhagic Cystitis, sponsored by AlloVir. Terminated at 56 sites in 7 countries. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by AlloVir · Phase 3, Interventional, and Treatment
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Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).
The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) in order to evaluate efficacy in this broader population (ITT Population).
AlloVir is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
Participants must meet all of the following criteria in order to be eligible to participate in the study:
Diagnosed with HC based on the following criteria (all 3 criteria must be met):
Key Exclusion Criteria
Participants who meet any of the following criteria will be excluded from participation in the study:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Biological: Placebo
Administered as 2-4 milliliter infusion, visually identical to placebo
Biological: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Time to Resolution of Macroscopic Hematuria
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.
Time frame: Up to 24 weeks
Time Until Bladder Pain is Resolved
Time frame: Until event occurrence through Week 24
Days in the Hospital for Any Reason
Time frame: Until event occurrence through Week 24
Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)
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.
Time frame: Up to 24 weeks
Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)
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.
Time frame: Up to 24 weeks
Time to Resolution for All Target Viruses
Time frame: Until event occurrence through Week 24
Average Daily Bladder Pain
Time frame: Until event occurrence through Week 6
Participants were enrolled from March 2021 to Jan 2024 across 57 study centers in the United States, Canada, France, Italy, Spain, Sweden, the United Kingdom and South Korea.
| Milestone | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| Started | 57 | 40 |
| Completed | 37 | 26 |
| Not completed | 20 | 14 |
| Withdrew: Not treated | 0 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Physician decision | 1 | 3 |
| Withdrew: Study terminated by sponsor | 5 | 3 |
| Withdrew: Withdrawal by subject | 10 | 5 |
| Withdrew: Other | 1 | 0 |
| Withdrew: Missing | 0 | 1 |
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.
| Days | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| Time to Resolution of Macroscopic Hematuria | 36 (22.0 to 63.0) | 31 (18.0 to 63.0) |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
| Participants | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD) | 11 | 9 |
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.
| Participants | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS) | 1 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Up to 24 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Posoleucel (ALVR105) | 2/57 (3.5%) | 28/57 (49.1%) | 54/57 (94.7%) |
| Placebo | 1/40 (2.5%) | 19/39 (48.7%) | 36/39 (92.3%) |
| Event | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 2/57 | 3/39 |
| PyrexiaGeneral disorders | 2/57 | 3/39 |
| PneumoniaInfections and infestations | 4/57 | 1/39 |
| NauseaGastrointestinal disorders | 3/57 | 0/39 |
| VomitingGastrointestinal disorders | 3/57 | 0/39 |
| Viral haemorrhagic cystitisInfections and infestations | 2/57 | 2/39 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/57 | 2/39 |
| Acute kidney injuryRenal and urinary disorders | 1/57 | 2/39 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/57 | 2/39 |
| HypotensionVascular disorders | 0/57 | 2/39 |
| Event | Posoleucel (ALVR105) | Placebo |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 4/57 | 9/39 |
| DiarrhoeaGastrointestinal disorders | 13/57 | 8/39 |
| HypokalaemiaMetabolism and nutrition disorders | 9/57 | 8/39 |
| PyrexiaGeneral disorders | 11/57 | 8/39 |
| NauseaGastrointestinal disorders | 11/57 | 3/39 |
| Abdominal painGastrointestinal disorders | 6/57 | 7/39 |
| RashSkin and subcutaneous tissue disorders | 0/57 | 7/39 |
| Blood creatinine increasedInvestigations | 6/57 | 6/39 |
| Acute graft versus host disease in intestineImmune system disorders | 8/57 | 3/39 |
| Urinary tract infectionInfections and infestations | 3/57 | 5/39 |
| Age, Continuous(years) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| Mean | 44.9 ± 16.59 | 47.0 ± 16.60 | 45.8 ± 16.54 |
| Sex: Female, Male(Participants) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| Female | 19 | 16 | 35 |
| Male | 38 | 24 | 62 |
| Ethnicity (NIH/OMB)(Participants) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 7 | 20 |
| Not Hispanic or Latino | 38 | 30 | 68 |
| Unknown or Not Reported | 6 | 3 | 9 |
| Race (NIH/OMB)(Participants) | Posoleucel (ALVR105) | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 7 | 3 | 10 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 9 | 2 | 11 |
| White | 33 | 30 | 63 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 5 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2021 to primary completion in Jan 2024, 34 months.
Results were first posted in May 2024, 3 months after primary completion.
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This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Posoleucel
Cystitis, Hemorrhagic
AlloVir