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Study of Viralym-M (ALVR105) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

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ClinicalTrials.gov Identifier: NCT04693637
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
AlloVir

Brief Summary:
The purpose of this study is to compare Viralym-M (ALVR105) to placebo for the prevention of six viruses of interest in high-risk patients post-Allogeneic Hematopoietic Cell Transplant

Condition or disease Intervention/treatment Phase
BK Virus Infection JC Virus Infection Epstein-Barr Virus Infections Cytomegalovirus Infections Adenovirus Infection Human Herpes Virus-6 Infection Biological: Viralym-M Cells Biological: Placebo (visually identical to Viralym-M) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Viralym-M Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Viralym-M (OL)
Open Label Cohort
Biological: Viralym-M Cells
Infusion

Placebo Comparator: Placebo
No Viremia Cohort & Viremia Cohort, Arm 2
Biological: Placebo (visually identical to Viralym-M)
Infusion

Experimental: Viralym-M
No Viremia Cohort & Viremia Cohort, Arm 1
Biological: Viralym-M Cells
Infusion




Primary Outcome Measures :
  1. To compare patients treated with Viralym-M to patients treated with placebo on the proportion of patients with clinically significant AdV, BKV, CMV, EBV, HHV-6, and/or JCV infection and/or end-organ disease [ Time Frame: Through Week 14 ]
    The proportion of patients on Viralym-M vs on Placebo with clinically significant AdV, BKV, CMV, EBV, HHV-6, and/or JCV infection


Secondary Outcome Measures :
  1. To compare patients treated with Viralym-M to patients treated with placebo on time to onset of AdV, BKV, CMV, EBV, HHV-6, and/or JCV [ Time Frame: Through Week 14 ]
    Time to onset of viruses of interest, Viralym-M compared to Placebo

  2. To compare patients treated with Viralym-M to patients treated with placebo on area under the curve (AUC) for cumulative viral load for AdV, BKV, CMV, EBV, HHV-6, and JCV [ Time Frame: Through Week 14 ]
  3. To compare patients treated with Viralym-M to patients treated with placebo on the proportion of patients with clearance of AdV, BKV, CMV, EBV, HHV-6, and/or JCV viremia in allogenic HCT patients [ Time Frame: Through Week 26 ]
    The proportion of patients on Viralym-M vs on Placebo with clearance of AdV, BKV, CMV, EBV, HHV-6, and/or JCV viremia

  4. To compare patients treated with Viralym-M to patients treated with placebo on the proportion of patients with clinically significant AdV, BKV, CMV, EBV, HHV-6, and/or JCV infection and/or end-organ diseases [ Time Frame: Through Week 26 ]
    Proportion of patients on Viralym-M vs on Placebo with clinically significant AdV, BKV, CMV, EBV, HHV-6, and/or JCV infection and/or end-organ diseases

  5. To compare patients treated with Viralym-M to patients treated with placebo on duration of hospitalization related to AdV, BKV, CMV, EBV, HHV-6, and/or JCV infection or disease [ Time Frame: Through Week 26 ]
    Duration of hospitalization

  6. To compare patients treated with Viralym-M to patients treated with placebo on proportion of patients with AdV, BKV, CMV, EBV, HHV-6, and/or JCV disease-related mortality [ Time Frame: Through Week 26 ]
    Proportion of patients with AdV, BKV, CMV, EBV, HHV-6, and/or JCV disease-related mortality

  7. FACT-BMT (Functional Assessment of Cancer Therapy - Bone Marrow Transplantation) score will be reported numerically and compared between baseline and end of treatment for both treatment groups [ Time Frame: Through Week 26 ]
    Comparison of Viralym-M to Placebo on patient-reported quality of life measures

  8. EQ-5D-5L will be reported as an index between baseline and end of treatment for both treatment groups [ Time Frame: Through Week 26 ]
    Comparison of Viralym-M to Placebo on age-appropriate patient-reported quality of life measures

  9. EQ5D-Y will be reported as an index between baseline and end of treatment for both treatment groups [ Time Frame: Through Week 26 ]
    Comparison of Viralym-M to Placebo on age-appropriate patient-reported quality of life measures

  10. EQ-5D-Y will be reported as an index between baseline and end of treatment for both treatment groups [ Time Frame: Through Week 26 ]
    Comparison of Viralym-M to Placebo on age-appropriate patient-reported quality of life measures

  11. To assess the incidence and severity of post-HCT safety AEs in patients treated with Viralym-M compared with placebo [ Time Frame: Through Week 26 ]
    Incidence and severity of Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have had a high-risk Allogeneic Hematopoietic Transplant within 15 to 42 days of first dose in study
  • Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening
  • At least 1 identified, suitably matched Viralym-M cell line for infusion is available
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
  • Contraceptive use by men and women consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Not pregnant or breastfeeding

Exclusion Criteria:

  • Has a history of AdV, BKV, CMV, HHV-6, and/or JCV end-organ disease within 6 months prior to treatment assignment
  • Evidence of active Grade >2 graft versus host disease (GVHD)
  • Presence of non-minor uncontrolled or progressive bacterial or fungal infections (ie, evidence of bacteremia, fungemia, disseminated)
  • Ongoing therapy with high-dose systemic corticosteroids
  • Pregnant or lactating or planning to become pregnant
  • Weight <30 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693637


Contacts
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Contact: Dee Rodriguez 833-409-2281 ClinicalTrials@allovir.com

Locations
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United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Hospital Recruiting
Westwood, Kansas, United States, 66205
United States, Missouri
Children's Mercy Kansas City Recruiting
Kansas City, Missouri, United States, 64108
United States, New York
Stony Brook University Hospital Cancer Center Recruiting
Stony Brook, New York, United States, 11794
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Sponsors and Collaborators
AlloVir
Publications:
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Responsible Party: AlloVir
ClinicalTrials.gov Identifier: NCT04693637    
Other Study ID Numbers: P-105-202
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AlloVir:
Hematopoietic Cell Transplant
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Adenoviridae Infections
Cytomegalovirus Infections
Epstein-Barr Virus Infections
DNA Virus Infections
Herpesviridae Infections
Tumor Virus Infections