Status:
TERMINATED
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
Lead Sponsor:
AlloVir
Conditions:
BK Virus Infection
Hemorrhagic Cystitis
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).
Detailed Description
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...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Participants must meet all of the following criteria in order to be eligible to participate in the study:
- Male or female ≥1 year of age.
- Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
- Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count \>10,000/mm³ at the time of randomization.
- Diagnosed with HC based on the following criteria (all 3 criteria must be met):
- Clinical signs and/or symptoms of cystitis.
- Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
- Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
- At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.
- Key Exclusion Criteria
- Participants who meet any of the following criteria will be excluded from participation in the study:
- Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose \>0.5 mg/kg/day or equivalent).
- Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
- Evidence of active Grade \>2 acute graft versus host disease (GVHD).
- Uncontrolled or progressive bacterial or fungal infections.
- Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
- Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
- Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
- Pregnant or lactating or planning to become pregnant.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04390113
Start Date
March 18 2021
End Date
January 30 2024
Last Update
May 14 2024
Active Locations (56)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States, 06520
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010