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The efficacy and safety of donor lymphocyte infusions for the treatment of Epstein-Barr virus-related post-transplant lymphoproliferative disorder after allogeneic hematopoietic stem cell transplantation for a phase 2 multi-center clinical trial

The efficacy and safety of donor lymphocyte infusions for the treatment of Epstein-Barr virus-related post-transplant lymphoproliferative disorder after allogeneic hematopoietic stem cell transplantation for a phase 2 multi-center clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084399
Enrollment
Unknown
Registered
2024-05-16
Start date
2024-05-17
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-transplant lymphoproliferative disorders

Interventions

Experimental group:dornor lymphocyte infusion

Sponsors

the Second Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) All patients receiving allogeneic hematopoietic stem cell transplantation, regardless of age; 2) Positive EBV-IgG antibody from a healthy donor (essential); 3) Patients who cannot tolerate R+CHOP chemotherapy after transplantation; 4) Patients who refused R+CHOP chemotherapy after transplantation; 5) Patients who cannot afford the cost of rituximab due to financial circumstances; 6) Patients with at least clinically diagnosed EBV-PTLD after allogeneic hematopoietic stem cell transplantation; 7) Expected survival =3 months; 8) No serious complications, AST, ALT and bilirubin were less than 2.5 times of the upper limit of normal, serum creatinine was less than 2 times of the upper limit of normal, and myocardial enzymes were less than 2 times of the upper limit of normal within 2 weeks before admission; 9) No GVHD performance; 10) No active infection; 11) Women of childbearing age must have a negative pregnancy test and consent to the use of effective contraception during treatment and for one year thereafter.

Exclusion criteria

Exclusion criteria: 1) 0-IV GVHD patients 2) Patients with severe infection; 3) Patients with recurrent leukemia; 4) Exclude patients at high risk of bleeding (patients with clear risk of gastrointestinal bleeding, abnormal coagulation function, receiving thrombolysis and anticoagulation therapy); 5) Those who are participating in other clinical trials or have participated in other drug clinical trials within 3 months; 7) Lactating, or not taking effective contraceptive measures, or pregnant women; 8) Unstable mental state; 9) Patients considered unsuitable for this regimen by the investigator.

Design outcomes

Primary

MeasureTime frame
Complete response rate;

Secondary

MeasureTime frame
overall survival;aGvHD rate;infection rate;Agranulocytic stage;thrombocytopenia rate ;immune reconstitution;

Countries

CHINA

Contacts

Public ContactYan jinsong

The second hospital of dalian medical university

yanjsdmu@126.com+86 139 0986 3628

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026