Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Cytomegalovirus Infections
Interventions
BIOLOGICAL

CMV-Peptide-Specific T cells

"In this phase I trial, five escalating dose levels will be tested. Each dose will be administered to groups of at least 3 and up to 6 patients. Dose escalation will be based on the dose limiting toxicity (DLT) observed in each treatment group (Confer Biostatistics).~The patient groups and donors are outlined as follows: Group I will receive a single dose of 5 x 105 T cells/kg body weight/dose; Group II will receive a single dose of 1 x 106 T cells/kg/dose; and group III will receive a single dose of 2 x 106 T cells/kg/dose; group IV will receive 3 weekly doses of 1 x 106 T cells/kg/dose; group V will receive 3 weekly doses of 2 x 106 T cells/kg/dose."

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00674648 - Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants | Biotech Hunter | Biotech Hunter