Allogeneic Hematopoietic Stem Cell TransplantationNCT07703657
A Randomized Controlled Trial of Prophylactic Rituximab to Reduce Clinically Significant EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
A study testing Rituximab (Arm A) and Standard Post-Transplant Supportive Care in people with Allogeneic Hematopoietic Stem Cell Transplantation and Epstein-Barr Virus Reactivation, run by Yang Donglin at 1 site in China.
Trial summary
This is a single-center, prospective, randomized, open-label clinical trial with blinded endpoint assessment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation, Epstein-Barr Virus Reactivation, Clinically Significant EBV DNAemia
- What is being tested?
- Rituximab (Arm A) and Standard Post-Transplant Supportive Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2026to 9 Jul 2027
- Phase
- Interventional
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged between 16 and 65 years old. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Clinically stable condition allowing administration of study intervention at post-transplant Day +21.
- EBV-DNA quantitative test completed within 48 hours prior to randomization. Written informed consent signed by the participant or legal authorized representative.
Who cannot join
- Presence of clinically significant EBV infection or meeting criteria for EBV preemptive therapy before randomization.
- Prior rituximab administration during conditioning regimen. Confirmed or highly suspected post-transplant lymphoproliferative disorder (PTLD).
- Severe anaphylactic history to rituximab or any excipients of the preparation. Active uncontrolled severe systemic infection. Active hepatitis B virus (HBV) infection without standardized antiviral prophylaxis or treatment.
- Pregnant or breastfeeding female subjects. Subjects judged ineligible for participation by the investigator for any other reason.
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
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Donglin Yang, 02223608592, yangdonglin@ihcams.ac.cn
About this study
Official title: A Prospective, Randomized, Controlled, Open-Label Clinical Trial With Blinded Endpoint Assessment of Prophylactic Rituximab for Reducing Clinically Significant EBV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
This is a single-center, prospective, randomized, open-label clinical trial with blinded endpoint assessment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). We aim to explore whether low-dose preventive rituximab can lower the risk of clinically significant Epstein-Barr virus (EBV) viremia within 180 days after transplantation.
Patients aged 16-65 years who receive allo-HSCT and carry medium-to-high risks of EBV reactivation will be enrolled. All eligible participants will be randomly split into two groups at day +21 after transplant at a 1:1 ratio.
Read more
Intervention group: Standard post-transplant supportive care plus two low doses of rituximab (100mg intravenous infusion on day +21 and day +28).
Control group: Only standard routine post-transplant management without preventive rituximab.
All participants will receive regular scheduled blood tests and outpatient follow-up visits up to 1 year after transplantation. We will monitor EBV viral load, cytomegalovirus (CMV) infection, graft-versus-host disease (GVHD), infection complications, immune function recovery, as well as long-term survival. We will also record all adverse reactions related to rituximab infusion, low immunoglobulin levels and other safety events.
The main study outcome is the cumulative rate of clinically significant EBV viremia within 180 days post transplant. All endpoint judgments will be completed by independent researchers to reduce assessment bias. This trial hopes to confirm the safety and clinical value of low-dose rituximab prevention, and provide reliable clinical evidence for EBV infection prevention after hematopoietic stem cell transplantation.
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Epstein-Barr Virus Reactivation, Clinically Significant EBV DNAemia
- Being tested
- Rituximab (Arm A), Standard Post-Transplant Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab (Arm A)Drug
Intervention Description Patients receive uniform standard allo-HSCT post-transplant care plus two low-dose prophylactic rituximab infusions: 100 mg IV on Day +21 and 100 mg IV on Day +28 after transplantation. Premedication is given before each infusion to avoid infusion reactions.
Standard Post-Transplant Supportive CareOther
Uniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Rituximab Group | Active comparator | Not described Receives: Drug: Rituximab (Arm A); Other: Standard Post-Transplant Supportive Care |
| Standard Care Control Group | Other | Not described Receives: Other: Standard Post-Transplant Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of clinically significant EBV DNAemia within 180 days after allogeneic hematopoietic stem cell transplantation
Measured: From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant
Secondary outcomes (3)
Incidence of any EBV DNAemia from randomization to Day +180 post-transplant
Measured: Randomization day to post-transplant Day 180
Cumulative incidence of post-transplant lymphoproliferative disorder (PTLD) within 1 year
Measured: Randomization day to post-transplant Day 365
1-year overall survival (OS)
Measured: Randomization day to post-transplant Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start9 Jul 2026 (estimated)
- Primary completion9 Jul 2027 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang Donglin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yang Donglin, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703657
- Sponsor's protocol ID
- IIT2026080-EC-1
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Open-Label Clinical Trial With Blinded Endpoint Assessment of Prophylactic Rituximab for Reducing Clinically Significant EBV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07703657
- Acronym / sponsor ID
- IIT2026080-EC-1
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation, Epstein-Barr Virus Reactivation, Clinically Significant EBV DNAemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Yang DonglinUniversity, hospital or other
- Study start
- 9 Jul 2026 (estimated)
- Primary completion
- 9 Jul 2027 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 14 Jul 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.
This is a single-center, prospective, randomized, open-label clinical trial with blinded endpoint assessment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). We aim to explore whether low-dose preventive rituximab can lower the risk of clinically significant Epstein-Barr virus (EBV) viremia within 180 days after transplantation.
Patients aged 16-65 years who receive allo-HSCT and carry medium-to-high risks of EBV reactivation will be enrolled. All eligible participants will be randomly split into two groups at day +21 after transplant at a 1:1 ratio.
Intervention group: Standard post-transplant supportive care plus two low doses of rituximab (100mg intravenous infusion on day +21 and day +28).
Control group: Only standard routine post-transplant management without preventive rituximab.
All participants will receive regular scheduled blood tests and outpatient follow-up visits up to 1 year after transplantation. We will monitor EBV viral load, cytomegalovirus (CMV) infection, graft-versus-host disease (GVHD), infection complications, immune function recovery, as well as long-term survival. We will also record all adverse reactions related to rituximab infusion, low immunoglobulin levels and other safety events.
The main study outcome is the cumulative rate of clinically significant EBV viremia within 180 days post transplant. All endpoint judgments will be completed by independent researchers to reduce assessment bias. This trial hopes to confirm the safety and clinical value of low-dose rituximab prevention, and provide reliable clinical evidence for EBV infection prevention after hematopoietic stem cell transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Rituximab Group | Active comparator | Drug: Rituximab (Arm A), Other: Standard Post-Transplant Supportive Care |
| Standard Care Control Group | Other | Other: Standard Post-Transplant Supportive Care |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 16 and 65 years old. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Clinically stable condition allowing administration of study intervention at post-transplant Day +21.
- EBV-DNA quantitative test completed within 48 hours prior to randomization. Written informed consent signed by the participant or legal authorized representative.
Key exclusion criteria (4 listed)
- Presence of clinically significant EBV infection or meeting criteria for EBV preemptive therapy before randomization.
- Prior rituximab administration during conditioning regimen. Confirmed or highly suspected post-transplant lymphoproliferative disorder (PTLD).
- Severe anaphylactic history to rituximab or any excipients of the preparation. Active uncontrolled severe systemic infection. Active hepatitis B virus (HBV) infection without standardized antiviral prophylaxis or treatment.
- Pregnant or breastfeeding female subjects. Subjects judged ineligible for participation by the investigator for any other reason.
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 |
|---|---|---|
| Rituximab (Arm A)Intervention Description Patients receive uniform standard allo-HSCT post-transplant care plus two low-dose prophylactic rituximab infusions: 100 mg IV on Day +21 and 100 mg IV on Day +28 after transplantation. Premedication is given before each infusion to avoid infusion reactions. | Drug | Prophylactic Rituximab Group |
| Standard Post-Transplant Supportive CareUniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring. | Other | Prophylactic Rituximab Group, Standard Care Control Group |
Primary outcome
Cumulative incidence of clinically significant EBV DNAemia within 180 days after allogeneic hematopoietic stem cell transplantation
Time frame: From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant
3 secondary outcomes
Incidence of any EBV DNAemia from randomization to Day +180 post-transplant
Time frame: Randomization day to post-transplant Day 180
Cumulative incidence of post-transplant lymphoproliferative disorder (PTLD) within 1 year
Time frame: Randomization day to post-transplant Day 365
1-year overall survival (OS)
Time frame: Randomization day to post-transplant Day 365
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 14 Jul 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 study testing Rituximab (Arm A) and Standard Post-Transplant Supportive Care in people with Allogeneic Hematopoietic Stem Cell Transplantation and Epstein-Barr Virus Reactivation, run by Yang Donglin 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Jul 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.
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 Donglin Yang (02223608592, yangdonglin@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of clinically significant EBV DNAemia within 180 days after allogeneic hematopoietic stem cell transplantation (time frame: From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant). 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 14 Jul 2026.