Condition or disease | Intervention/treatment | Phase |
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CMV CMV Infection Hematopoietic Cell Transplant | Drug: Letermovir Pill Other: blood draw | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 86 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Single-arm Study of Letermovir (LTV) for Prevention of Recurrent CMV Infection in High-risk Hematopoietic Cell Transplant (HCT) Recipients |
Actual Study Start Date : | July 19, 2019 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |
Arm | Intervention/treatment |
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Experimental: Hematopoietic cell transplantation/HCT
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. OBSERVATIONAL COHORT: Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180. |
Drug: Letermovir Pill
Patients enrolled on the study will receive oral LTV 480 mg daily (240 mg daily for patients receiving cyclosporine A). The maximum duration of LTV administration will be 14 weeks. Patients receiving oral medication will be administered a pill diary for drug compliance purposes. This will be administered and reconciled in clinic.
Other Name: LTV
Other: blood draw Collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have one or more risk factors for recurrent CMV infection:
Human leukocyte antigen (HLA) mismatch
Subject eligibility criteria for the observational cohort:
Exclusion Criteria:
Exclusion criteria for observational cohort:
Contact: Genovefa Papanicolaou, MD | 347-501-0044 | papanicg@mskcc.org | |
Contact: Yeon Joo Lee, MD | 212-639-8180 | leey3@mskcc.org |
United States, Minnesota | |
University of Minnesota | Not yet recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Jo-Anne Young, MD 612-624-9996 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Genovefa Papanicolaou, MD 347-501-0044 |
Principal Investigator: | Genovefa Papanicolaou | Memorial Sloan Kettering Cancer Center |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 10, 2019 | ||||||||
First Posted Date ICMJE | July 12, 2019 | ||||||||
Last Update Posted Date | March 11, 2021 | ||||||||
Actual Study Start Date ICMJE | July 19, 2019 | ||||||||
Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
The rate of breakthrough clinically significant Cytomegalovirus (CMV) infection by week 14 [ Time Frame: up to 24 weeks from time of study treatment ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection | ||||||||
Official Title ICMJE | An Open-label, Single-arm Study of Letermovir (LTV) for Prevention of Recurrent CMV Infection in High-risk Hematopoietic Cell Transplant (HCT) Recipients | ||||||||
Brief Summary | The purpose of this study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Hematopoietic cell transplantation/HCT
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. OBSERVATIONAL COHORT: Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180. Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
86 | ||||||||
Original Estimated Enrollment ICMJE |
36 | ||||||||
Estimated Study Completion Date ICMJE | July 2023 | ||||||||
Estimated Primary Completion Date | July 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Subject eligibility criteria for the observational cohort:
Exclusion Criteria:
Exclusion criteria for observational cohort:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04017962 | ||||||||
Other Study ID Numbers ICMJE | 19-174 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
Collaborators ICMJE | Merck Sharp & Dohme Corp. | ||||||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |