RECRUITING

Prospect Eval of Efficacy of CMV-TCIP Direct Letermovir Prophylax After Allogen Hemato Cell Transpla

Conditions

CMV Allogeneic Stem Cell Transplantation CMV T Cell Immunity Panel CMV reactivation Letermovir

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.

Official Title

Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Quick Facts

Study Start:2024-06-27

Study Completion:2029-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06453460

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥ 18 years of age on the day of signing informed consent. * Karnofsky performance \>70% * Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT. * Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells. * Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment. * Be within 28 days post-HSCT at the time of enrollment. * Be able to comply with medical recommendations or follow-up. * Has adequate organ functions determined by 1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula). 2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease. 3. ALT or AST ≤200 IU/ml for adults. 4. Conjugated (direct) bilirubin \< 2x upper limit of normal. 5. Left ventricular ejection fraction ≥40%. 6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.	* Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment. * Received within 7 days prior to screening or plans to receive during the study any of the following: 1. Ganciclovir 2. Valganciclovir 3. Foscarnet 4. Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day) 5. Valacyclovir (\> 3000 mg/day) 6. Famciclovir (\> 1500 mg/day) * Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy. * Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations. * Has an uncontrolled infection on the day of randomization. * Requires mechanical ventilation or is hemodynamically unstable at the time of randomization.

Inclusion Criteria

Exclusion Criteria

* ≥ 18 years of age on the day of signing informed consent.
* Karnofsky performance \>70%
* Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.
* Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.
* Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
* Be within 28 days post-HSCT at the time of enrollment.
* Be able to comply with medical recommendations or follow-up.
* Has adequate organ functions determined by
1. Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).
2. Bilirubin ≤1.5 mg/dl except for Gilbert's disease.
3. ALT or AST ≤200 IU/ml for adults.
4. Conjugated (direct) bilirubin \< 2x upper limit of normal.
5. Left ventricular ejection fraction ≥40%.
6. Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.

* Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
* Received within 7 days prior to screening or plans to receive during the study any of the following:
1. Ganciclovir
2. Valganciclovir
3. Foscarnet
4. Acyclovir (\> 3200 mg PO per day or \> 25 mg/kg IV per day)
5. Valacyclovir (\> 3000 mg/day)
6. Famciclovir (\> 1500 mg/day)
* Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.
* Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
* Has an uncontrolled infection on the day of randomization.
* Requires mechanical ventilation or is hemodynamically unstable at the time of randomization.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

Piyanuch Kongtim, MD,PhD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center, University of California Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

Piyanuch Kongtim, MD,PhD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27

Study Completion Date2029-06

Study Record Updates

Study Start Date2024-06-27

Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

CMV T Cell Immunity Panel
CMV reactivation
Allogeneic stem cell transplantation
Letermovir

Additional Relevant MeSH Terms

CMV
Allogeneic Stem Cell Transplantation