CMV-TCIP Directed Letermovir Prophylaxis After Allo-SCT

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage the risk of Cytomegalovirus (CMV) in patients who have recently received an allogeneic stem cell transplant. CMV can cause serious health problems, especially in people with weakened immune systems. The trial is testing a tool called the CMV T Cell Immunity Panel (CMV-TCIP) to help doctors decide how long patients need to take medication to prevent CMV infection. Researchers are looking for adult participants who are at least 18 years old, have a positive CMV status, and are within 28 days of their stem cell transplant.

Eligible participants will be closely monitored during the study and will receive treatment to help prevent CMV. They will also need to meet certain health criteria, such as having adequate organ function and no recent severe CMV infections. Overall, this trial hopes to find a more effective way to protect patients from CMV after their transplant, which could improve their recovery and long-term health. If you or a loved one are interested, it’s a good idea to discuss this with your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • Must be within Day-10 thru Day+28 days of planned 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.
• Exclusion Criteria:
• • 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
• • Requires mechanical ventilation or is hemodynamically unstable