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Low-dose CD20 Monoclonal Antibody Injection in Preemptive Treatment of PTLD in Patients With EBV-HLH/CAEBV

NCT ID: NCT05258136

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-06-01

Brief Summary

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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

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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 doseā‰¤ 4 applications per patient

Conditions

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PTLD CAEBV HLH

Keywords

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preemptive therapy, CD20 monoclonal antibody

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EBV-DNA positive patients

EBV-DNA positive patients

Group Type EXPERIMENTAL

low-dose CD20 monoclonal antibody injection

Intervention Type DRUG

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

Interventions

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low-dose CD20 monoclonal antibody injection

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Cui

Role: STUDY_DIRECTOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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EBV reactivation

Identifier Type: -

Identifier Source: org_study_id