Health Condition 1: B349- Viral infection, unspecified
Conditions
Interventions
Intervention1: CD45 RA depleted product: CD45 RA depleted product
Day 0 D7 D28 and D60
Control Intervention1: Not applicable: Not applicable
Sponsors
WellcomeDBT India Alliance
Eligibility
Inclusion criteria
Inclusion criteria: Patients undergoing Haplo-identical stem cell transplantation
Exclusion criteria
Exclusion criteria: 1.CMV reactivation ( >3 log copy number by DNA PCR in whole blood) in pre-transplant testing 2.Creatinine clearance >60 ml/min 3.Left ventricular ejection fraction >40% 4.Total bilirubin 5.No on-going gram negative blood stream infection 6.Systolic blood pressure >100mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute GVHD grade 3 to 4 - measured weekly up to Day 150Timepoint: Incidence of acute GVHD grade 3 to 4 - measured weekly up to Day 150 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1: CMV reactivation by weekly quantitative PCR on whole blood upto Day 100 (3 log copy number in whole blood) necessitating pre-emptive therapy. Secondary outcome 2 : BK reactivation by weekly quantitative PCR on urine upto Day 100 (7 log copy number in urine ) necessitating pre-emptive therapy â?¢Secondary outcome 3: Absolute levels of T cell subsets in peripheral blood at Day 60, 100 and 150Timepoint: Day 60, 100 and 150 | — |
Countries
India
Contacts
Public ContactBiju George Christian Medical College
Christian Medical College
Outcome results
None listed