Hematologic Malignancy
Conditions
Brief summary
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
Detailed description
Hematopoietic stem cell transplantation (HSCT) represents the only potentially curative modality for hematologic malignancies. Nevertheless, post-transplant infections substantially elevate the risk of transplant-related mortality, with cytomegalovirus (CMV) infection being among the most prevalent complications. Although advances in prophylactic strategies and preemptive antiviral therapy have contributed to a measurable reduction in both the incidence of CMV infection and CMV disease, refractory or drug-resistant (R/R) CMV infection following HSCT remains a significant global therapeutic challenge. Recent epidemiologic data indicate that the incidence of drug-resistant CMV infection in HSCT recipients ranges from 1.7% to 14.5%, while that of refractory CMV infection falls between 29% and 39%. Notably, in China, the incidence of refractory CMV infection after HSCT is slightly higher than the global average-approximately 47% . Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore the efficacy of different durations of Maribavir treatment regimens in Allo-HSCT.
Interventions
DRUGMaribavir
During the treatment period, maribavir is administered orally at a dosage of 400 mg twice daily. Participants will be stratified by clinical trial and received oral medication for varying durations.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. First allogeneic hematopoietic stem cell transplantation; 2. Age ≥ 18 years; 3. Confirmed refractory CMV infection; Refractory CMV infection is defined as fulfillment of any one of the following criteria: * Persistent or increasing CMV viremia despite ≥2 weeks of appropriate antiviral therapy-specifically, CMV DNA levels remain unchanged (i.e., change ≤ log₁₀) or increase (i.e., change \> log₁₀)-concomitant with lack of clinical improvement or ongoing disease progression; * Drug-resistant CMV infection-defined as detection of specific CMV gene mutations associated with reduced susceptibility to one or more anti-CMV agents, in patients who otherwise meet the criteria for refractory CMV infection; * Intolerance to anti-CMV therapy-defined as inability to continue antiviral treatment due to severe adverse effects, such as clinically significant bone marrow suppression or renal impairment; 4. Provision of written informed consent and willingness to participate in this clinical study.
Exclusion criteria
1. Known allergic constitution, particularly hypersensitivity to any component of maribavir; 2. Active hepatitis B infection, defined as HBV DNA level ≥ 1 × 10³ IU/mL; 3. Confirmed HIV infection; 4. Severe impairment of major organ function, including but not limited to respiratory failure, cardiac failure, decompensated hepatic insufficiency, or renal insufficiency; 5. Central nervous system CMV infection; 6. History of substance use disorder or chronic alcoholism that may compromise the validity or interpretation of trial outcomes; 7. Presence of a psychiatric disorder or cognitive impairment precluding the provision of informed consent; 8. Any other condition deemed by the investigator to render the participant unsuitable for enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of recurrent CMV infection | The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT | The incidence of recurrent CMV infection within 8 weeks after maribavir discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of recurrent CMV infection | The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT | The incidence of recurrent CMV infection within 16 weeks after maribavir discontinuation |
| The incidence of recurrent CMV disease | Follow-up is conducted for 8 weeks following maribavir discontinuation. | The incidence of recurrent CMV disease within 8 weeks after maribavir discontinuation |
| CMV resistance mutations | Through study completion. It is expected within one year post-transplant. | The incidence of CMV resistance mutations |
Countries
China
Contacts
CONTACTXiaoxia Hu
CONTACTLuxiang Wang
Outcome results
None listed