Status:
TERMINATED
Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Chronic Lymphocytic Leukemia
CML (Chronic Myelogenous Leukemia)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Allogeneic hematopoetic stem cell transplantation (SCT) is frequently complicated by life threatening viral reactivation. Conventional antiviral therapy is suboptimal for cytomegalovirus (CMV), adenov...
Detailed Description
Allogeneic hematopoetic stem cell transplantation (SCT) is frequently complicated by life threatening viral reactivation. Conventional antiviral therapy is suboptimal for cytomegalovirus (CMV), adenov...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA: Recipient
- Ages 18-75 years inclusive
- Patients with hematologic malignancies who have signed consent for NHLBI transplant protocol 13-H-0144.
- Susceptible to CMV reactivation post transplant (either donor or recipient need to be seropositive for CMV at any time prior to transplant).
- Ability to comprehend the investigational nature of the study and provide informed consent.
- EXCLUSION CRITERIA: Recipient
- Positive pregnancy test for women of childbearing age.
- DLCO adjusted for Hb and ventilation \< 50% predicted prior to SCT
- Left ventricular ejection fraction \< 40% (evaluated by ECHO) or \< 30% (evaluated by MUGA) prior to SCT
- AST/SGOT \> 10 times ULN (\>grade 3, CTCAE)
- Bilirubin \> 5 times ULN (\>grade 3, CTCAE)
- Estimated GFR \< 15 mL/min
- Receiving Ganciclovir, Foscarnet or Cidofovir
- Receiving corticosteroids at the dose equivalent to 0.5 mg/kg/day of methylprednisolone
- Evidence of active autoimmune process
Exclusion
Key Trial Info
Start Date :
September 3 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02231853
Start Date
September 3 2014
End Date
December 29 2017
Last Update
December 17 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892