PTLDNCT05258136
Low-dose CD20 Monoclonal Antibody Injection in Preemptive Treatment of PTLD in Patients With EBV-HLH/CAEBV
A study testing low-dose CD20 monoclonal antibody injection in people with PTLD and CAEBV, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a clinical study on the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV Read more about this study
- Who is it for?
- Ages Up to 65 years
- What is being tested?
- low-dose CD20 monoclonal antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PTLD patients undergoing allo-HSCT with CAEBV or EBV-HLH met the following conditions: (1) EBV-DNA (PBMC or plasma) > 1000 copies/ml in peripheral blood after transplantation; (2) no PTLD symptoms; (3) presence of aGVHD or clinicians believe that RI treatment is not suitable, or EBV-DNA persists > 1000 copies/ml after RI; (4) EBV infected lymphocytes; (4) B cell infection, or B cell copy number higher than other cell lines by 2 logs.
Who cannot join
- Patients with active infection except for EBV; Active hepatitis B or C (positive HBV-DNA or HCV-RNA) ; Known life-threatening allergic reactions to CD20 Monoclonal Antibody Injection or its preparation ingredients; Participate in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on the Efficacy and Safety of Low-dose CD20 Monoclonal Antibody Injection in Preemptive Treatment of Lymphoproliferative Diseases After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With EBV-HLH/CAEBV
This is a clinical study on the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV
Read the detailed description
Purpose: To comprehend the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV Study subjects: PTLD patients undergoing allo-HSCT with CAEBV or EBV-HLH met the following conditions: (1) EBV-DNA (PBMC or plasma) > 1000 copies/ml in peripheral blood after transplantation; (2) no PTLD symptoms; (3) presence of aGVHD or clinicians believe that RI treatment is not suitable, or EBV-DNA persists > 1000 copies/ml after RI; (4) EBV infected lymphocytes; (4) B cell infection, or B cell copy number higher than other cell lines by 2 logs.
Therapeutic regimen: CD20 monoclonal antibody injection 100 mg/m2 was intravenously infused once a week. It can be discontinued after EBV-DNA negative for 2 consecutive times. Total dose≤ 4 applications per patient
- Being tested
- low-dose CD20 monoclonal antibody injection
- Keywords
- preemptive therapy, CD20 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose CD20 monoclonal antibody injectionDrug
To comprehend the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV
| Study group | Role | What they receive |
|---|---|---|
| EBV-DNA positive patients | Experimental | EBV-DNA positive patients Receives: Drug: low-dose CD20 monoclonal antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
EBV-DNA
Incidence of negative ebv-dna conversion
Measured: 4 weeks
PTLD
Incidence of PTLD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTLDStudies of the same condition, open and under way.
- More trials run by Beijing Friendship 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Cui, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258136
- Sponsor's protocol ID
- EBV reactivation
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 28 Feb 2022
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Low-dose CD20 Monoclonal Antibody Injection in Preemptive Treatment of Lymphoproliferative Diseases After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With EBV-HLH/CAEBV
- ClinicalTrials.gov ID
- NCT05258136
- Acronym / sponsor ID
- EBV reactivation
- Keywords
- preemptive therapy, CD20 monoclonal antibody
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 28 Feb 2022 (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 clinical study on the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV
Detailed description
Purpose: To comprehend the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV Study subjects: PTLD patients undergoing allo-HSCT with CAEBV or EBV-HLH met the following conditions: (1) EBV-DNA (PBMC or plasma) > 1000 copies/ml in peripheral blood after transplantation; (2) no PTLD symptoms; (3) presence of aGVHD or clinicians believe that RI treatment is not suitable, or EBV-DNA persists > 1000 copies/ml after RI; (4) EBV infected lymphocytes; (4) B cell infection, or B cell copy number higher than other cell lines by 2 logs.
Therapeutic regimen: CD20 monoclonal antibody injection 100 mg/m2 was intravenously infused once a week. It can be discontinued after EBV-DNA negative for 2 consecutive times. Total dose≤ 4 applications per patient
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBV-DNA positive patients | Experimental | Drug: low-dose CD20 monoclonal antibody injectionEBV-DNA positive patients |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- PTLD patients undergoing allo-HSCT with CAEBV or EBV-HLH met the following conditions: (1) EBV-DNA (PBMC or plasma) > 1000 copies/ml in peripheral blood after transplantation; (2) no PTLD symptoms; (3) presence of aGVHD or clinicians believe that RI treatment is not suitable, or EBV-DNA persists > 1000 copies/ml after RI; (4) EBV infected lymphocytes; (4) B cell infection, or B cell copy number higher than other cell lines by 2 logs.
Key exclusion criteria (1 listed)
- Patients with active infection except for EBV; Active hepatitis B or C (positive HBV-DNA or HCV-RNA) ; Known life-threatening allergic reactions to CD20 Monoclonal Antibody Injection or its preparation ingredients; Participate in other clinical studies.
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 |
|---|---|---|
| low-dose CD20 monoclonal antibody injectionTo comprehend the efficacy and safety of low-dose CD20 monoclonal antibody injection in preemptive treatment of EBV positive lymphoproliferative diseases after allo-HSCT in patients with EBV-HLH and CAEBV | Drug | EBV-DNA positive patients |
Primary outcome
EBV-DNA
Time frame: 4 weeks
Incidence of negative ebv-dna conversion
PTLD
Time frame: 1 year
Incidence of PTLD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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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. This study is not recruiting at the moment.
Yan Cui study director
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-dose CD20 monoclonal antibody injection in people with PTLD and CAEBV, run by Beijing Friendship 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EBV-DNA (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 28 Feb 2022.