Evaluating CMV Prophylaxis After Stem Cell Transplant

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

This study is testing if a new test can help doctors decide how long to give a specific medicine to prevent a virus in patients who have had a stem cell transplant.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Irvine (other)
• Locations: 1 site (Orange, California)
• Trial ID: NCT06453460 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial investigates the effectiveness of the CMV T Cell Immunity Panel (CMV-TCIP) assay in determining the duration of CMV prophylaxis using Letermovir for patients who are CMV-seropositive and have undergone allogeneic stem cell transplantation. The study aims to optimize CMV management by tailoring prophylactic treatment based on individual immune responses. Participants will be monitored for CMV reactivation and overall health outcomes following their transplant.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are CMV-seropositive and within 28 days post-allogeneic stem cell transplantation.

Not a fit: Patients who are CMV-negative or those who do not meet the eligibility criteria for organ function and performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective CMV management in stem cell transplant recipients, potentially reducing the risk of CMV reactivation.

How similar studies have performed: Other studies have shown promise in using immune monitoring to guide CMV prophylaxis, suggesting that this approach may be effective.

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

Where this trial is running

Orange, California

• Chao Family Comprehensive Cancer Center, University of California Irvine — Orange, California, United States (RECRUITING)

Study contacts

• Principal investigator: Piyanuch Kongtim, MD,PhD — Chao Family Comprehensive Cancer Center
• Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine

Conditions: CMV, Allogeneic Stem Cell Transplantation, CMV T Cell Immunity Panel, CMV reactivation, Allogeneic stem cell transplantation, Letermovir