Hematologic MalignancyPhase 3NCT07511127
Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Allo-HSCT
A Phase 3 study testing Maribavir in people with Hematologic Malignancy, run by Ruijin Hospital at 1 site in China.
Trial summary
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Maribavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First allogeneic hematopoietic stem cell transplantation;
- Age ≥ 18 years;
- 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;
- Provision of written informed consent and willingness to participate in this clinical study.
Who cannot join
- Known allergic constitution, particularly hypersensitivity to any component of maribavir;
- Active hepatitis B infection, defined as HBV DNA level ≥ 1 × 10³ IU/mL;
- Confirmed HIV infection;
- Severe impairment of major organ function, including but not limited to respiratory failure, cardiac failure, decompensated hepatic insufficiency, or renal insufficiency;
- Central nervous system CMV infection;
- History of substance use disorder or chronic alcoholism that may compromise the validity or interpretation of trial outcomes;
- Presence of a psychiatric disorder or cognitive impairment precluding the provision of informed consent;
- Any other condition deemed by the investigator to render the participant unsuitable for enrollment in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai
Luxiang Wang, +86 021 64370045, wlx12369@rjh.com.cn
About this study
Official title: Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Patients With Refractory Cytomegalovirus Infection Following Allo-HSCT: a Prospective, Multicenter, Randomized, Controlled Clinical Trial
To comparing the efficacy of different durations of Maribavir treatment regimens in patients suffering from refractory CMV infection after allo-HSCT.
Read the 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.
- Conditions
- Hematologic Malignancy
- Being tested
- Maribavir
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaribavirDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fixed-duration group | Active comparator | The fixed-duration group that discontinued maribavir treatment after 8 weeks. Receives: Drug: Maribavir |
| PCR-guided group | Experimental | The experimental group discontinued maribavir after achieving two consecutive negative CMV-DNA PCR test, with a one-week interval, following drug administration. Receives: Drug: Maribavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of recurrent CMV infection
The incidence of recurrent CMV infection within 8 weeks after maribavir discontinuation
Measured: The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT
Secondary outcomes (3)
The incidence of recurrent CMV infection
The incidence of recurrent CMV infection within 16 weeks after maribavir discontinuation
Measured: The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV disease
The incidence of recurrent CMV disease within 8 weeks after maribavir discontinuation
Measured: Follow-up is conducted for 8 weeks following maribavir discontinuation.
CMV resistance mutations
The incidence of CMV resistance mutations
Measured: Through study completion. It is expected within one year post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start28 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511127
- Sponsor's protocol ID
- RJBMT-2026CMV
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Different Durations of Maribavir Treatment Regimens in Patients With Refractory Cytomegalovirus Infection Following Allo-HSCT: a Prospective, Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07511127
- Acronym / sponsor ID
- RJBMT-2026CMV
- Conditions
- Hematologic Malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed-duration group | Active comparator | Drug: MaribavirThe fixed-duration group that discontinued maribavir treatment after 8 weeks. |
| PCR-guided group | Experimental | Drug: MaribavirThe experimental group discontinued maribavir after achieving two consecutive negative CMV-DNA PCR test, with a one-week interval, following drug administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- First allogeneic hematopoietic stem cell transplantation;
- Age ≥ 18 years;
- Confirmed refractory CMV infection;
- Provision of written informed consent and willingness to participate in this clinical study.
Key exclusion criteria (8 listed)
- Known allergic constitution, particularly hypersensitivity to any component of maribavir;
- Active hepatitis B infection, defined as HBV DNA level ≥ 1 × 10³ IU/mL;
- Confirmed HIV infection;
- Severe impairment of major organ function, including but not limited to respiratory failure, cardiac failure, decompensated hepatic insufficiency, or renal insufficiency;
- Central nervous system CMV infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaribavirDuring 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. | Drug | Fixed-duration group, PCR-guided group |
Primary outcome
The incidence of recurrent CMV infection
Time frame: 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
3 secondary outcomes
The incidence of recurrent CMV infection
Time frame: The secondary endpoint is assessed 16 weeks after maribavir discontinuation following allo-HSCT
The incidence of recurrent CMV disease
Time frame: Follow-up is conducted for 8 weeks following maribavir discontinuation.
CMV resistance mutations
Time frame: Through study completion. It is expected within one year post-transplant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maribavir in people with Hematologic Malignancy, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoxia Hu (+86-021-64370045, hxx12276@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of recurrent CMV infection (time frame: The primary endpoint is assessed 8 weeks after maribavir discontinuation following allo-HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.