NCT05258136

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

February 24, 2022

Last Update Submit

February 24, 2022

Conditions

PTLDCAEBVHLH

Keywords

preemptive therapy, CD20 monoclonal antibody

Outcome Measures

Primary Outcomes (2)

  • EBV-DNA

    Incidence of negative ebv-dna conversion

    4 weeks

  • PTLD

    Incidence of PTLD

    1 year

Study Arms (1)

EBV-DNA positive patients

EXPERIMENTAL

EBV-DNA positive patients

Drug: low-dose CD20 monoclonal antibody injection

Interventions

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

EBV-DNA positive patients

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Study Officials

  • Yan Cui

    Beijing Friendship Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2022

First Posted

February 28, 2022

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

February 28, 2022

Record last verified: 2022-02

Locations

CN(1)