Pre-emptive treatment of epstein-barr virus (EBV)-associated lymphoproliferative disorder (LPD) and post-transplantational lymphoproliferative disorder (PTLD) with EBV-specific immune effector cell (EBV-IE)

Completed

• Conditions: EBV-related diseases; Infections and Infestations; Infectious mononucleosis

• Registration Number: ISRCTN26640234
• Lead Sponsor: Vectorite Biomedica Inc. (Taiwan)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. The participants should meet at least one of the following conditions:
1.1. Bone marrow transplant (BMT) or solid organ transplant (SOT) patient:
1.1.1. High-risk subject of developing LPD: donor is EBV sero-positive (EBV-VCA IgG+) while subject is EBV sero-negative (EBV-VCA IgG-)
1.1.2. The subject has history of EBV-LPD or EBV-related malignancy
1.1.3. The subject with EBV-LPD and is not adaptable for conventional treatment
1.1.4. The subject shows EBV DNA greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
1.1.5. The subject with the symptoms of EBV reactivation (fever, diarrhoea or lymphadenopathy) and confirmed by biopsy examination, regardless of the EBV level
1.2. EBV-infected subjects without BMT/SOT:
1.2.1. Subject develops EBV-LPD and not suitable for conventional treatment
1.2.2. The subject shows EBV DNA greater than or equal to 1000 genome copies/µg in the peripheral blood (with or without LPD) in two consecutive samplings (24 hours apart)
1.2.3. The subject with the symptoms of EBV reactivation (fever, diarrhoea or lymphadenopathy) and confirmed by biopsy examination, regardless of the EBV level
2. Aged less than or equal to 65 years old
3. Subject blood:
3.1. White blood cell count (WBC) greater than or equal to 3500/µl
3.2. Blood lymphocytes greater than or equal to 750/µl
4. Liver and kidney function:
4.1. Creatinine less than or equal to 1.25 times of upper limit
4.2. Bilirubin less than or equal to 1.5 times of upper limit
4.3. Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times of upper limit
4.4. Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times of upper limit
5. Donor condition:
5.1. No chemo- or radiotherapy within 4 weeks of blood collection; no steroid use within 1 week of blood collection
5.2. WBC greater than or equal to 3500/µl
5.3. Lymphocytes greater than or equal to 750/µl
6. Signed informed consent

Exclusion Criteria

1. Donor or recipient is positive for hepatitis C virus (HCV) (HCV antibody), human immunodeficiency virus (HIV) (HIV antibody) or tuberculosis (TB) (TB culture)
2. Recipient develops grade IV graft-versus-host disease (GvHD)
3. Recipient is albumin-intolerant
4. Recipient life expectancy is less than 8 weeks
5. Recipient received alternative cell therapy within 30 days
6. Recipient is pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified