Cellular therapy in patients with cancer undergoing bone marrow transplantatio
Not Applicable
- Conditions
- Health Condition 1: B349- Viral infection, unspecified
- Registration Number
- CTRI/2021/03/032020
- Lead Sponsor
- WellcomeDBT India Alliance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients undergoing Haplo-identical stem cell transplantation
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 <=3 times the upper limit
5.No on-going gram negative blood stream infection
6.Systolic blood pressure >100mmHg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 <br/ ><br>â?¢Secondary outcome 3: Absolute levels of T cell subsets in peripheral blood at Day 60, 100 and 150Timepoint: Day 60, 100 and 150