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

HLH Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05258136
• Other study ID #: EBV reactivation
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2022
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• CAEBV
• HLH
• PTLD

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EBV-DNA	Incidence of negative ebv-dna conversion	4 weeks
Primary	PTLD	Incidence of PTLD	1 year