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Virus Therapy
Posoleucel for Hemorrhagic Cystitis
Phase 3
Waitlist Available
Research Sponsored by AlloVir
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until event occurance through week 24
Awards & highlights
Study Summary
This trial will test a new treatment for viruses that targets six different types of viruses.
Who is the study for?
This trial is for males and females over 1 year old who had a bone marrow transplant between 21 days to 1 year ago, have stable blood counts, and are diagnosed with severe bladder inflammation due to viral infection. It's not for pregnant women, those on high-dose steroids or recent recipients of certain immune therapies, nor patients with uncontrolled infections or lung disease.Check my eligibility
What is being tested?
The study tests posoleucel (ALVR105), a T cell therapy targeting six viruses that can cause serious infections after bone marrow transplants. Participants will either receive this treatment or a placebo to compare effectiveness in treating virus-associated hemorrhagic cystitis.See study design
What are the potential side effects?
While the specific side effects of posoleucel (ALVR105) aren't detailed here, similar treatments may cause reactions at the infusion site, flu-like symptoms, fatigue, headache, and could potentially worsen existing infections or trigger new ones.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
There is at least one suitable posoleucel (ALVR105) cell line available for infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until event occurance through week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until event occurance through week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time until urine is visually clear of hematuria
Secondary outcome measures
Average daily bladder/lower abdominal pain
Days in the hospital for any reason
Incidence and severity of acute graft versus host disease and cytokine release syndrome
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Posoleucel (ALVR105)Experimental Treatment1 Intervention
Administered as 2-4 milliliter infusion, visually identical to placebo
Group II: PlaceboPlacebo Group1 Intervention
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
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Who is running the clinical trial?
AlloVirLead Sponsor
11 Previous Clinical Trials
658 Total Patients Enrolled
4 Trials studying BK Virus Infection
474 Patients Enrolled for BK Virus Infection
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an ongoing viral infection that is getting worse and cannot be treated with posoleucel.You are currently taking a high dose of corticosteroids.You cannot have received certain medications that suppress the immune system within 28 days before the start of the study.You have severe ongoing graft versus host disease.You had a specific type of transplant involving blood cells within the past year.You have a specific type of lymphatic disorder that is not under control or is getting worse.You have been diagnosed with hemorrhagic cystitis based on certain clinical signs and symptoms, including severe blood in the urine and the presence of certain viruses.You have pneumonia caused by an organism that is not being well-controlled by antibiotics.You have a certain level of white blood cells and platelets in your body for three days in a row.There is at least one suitable posoleucel (ALVR105) cell line available for infusion.You are at least 1 year old, regardless of gender.You have an infection that is not being controlled or is getting worse.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Posoleucel (ALVR105)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any negative side effects of taking ALVR105 (Viralym-M)?
"There is some evidence suggesting that ALVR105 (Viralym-M) is efficacious and safe, as this medication has progressed to Phase 3 clinical trials."
Answered by AI
Are there still places available for people who want to participate in this research?
"The clinical trial detailed on clinicaltrials.gov is looking for participants and was last updated on 3/16/2022."
Answered by AI
What is the total number of people who have signed up for this research project?
"In order to reach the goal of 125 enrollees, this study needs patients that meet specific inclusion criteria from various locations including Mount Sinai Medical Center and Dana-Farber Cancer Institute."
Answered by AI
How many different hospitals or research facilities are participating in this project?
"Presently, 33 different clinical sites are recruiting patients for this trial. A few examples of locations where these centres can be found include New york, Boston and Denver. If you wish to enroll in the study, it is recommended that you choose the location nearest to you to limit travel as much as possible."
Answered by AI
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