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RATIONALE: Cytomegalovirus-specific adoptive cellular therapy and standard antiviral drug therapy may be effective in preventing and treating recurrent cytomegalovirus infections in patients who have undergone stem cell transplant. It is not yet known whether one type of adoptive cellular therapy is more effective than another type in preventing cytomegalovirus infections.
PURPOSE: This randomized phase III trial is comparing standard antiviral drug therapy with two types of adoptive cellular therapy in treating cytomegalovirus infections in patients after donor stem cell transplant.
- To evaluate the potential clinical benefit of immunoprophylactic cytomegalovirus (CMV)-specific adoptive cellular therapy (ACT) and conventional antiviral drug therapy following T-cell-depleted allogeneic hematopoietic stem cell transplantation in terms of reduction in number of recurrent CMV reactivations.
- To evaluate the effect of ACT on graft-versus-host disease (GVHD) incidence.
- To evaluate the effect of ACT on total days of CMV viremia and duration of antiviral drug therapy.
- To evaluate the effect of the selection process (hence cellular composition) of ACT on clinical and immunological endpoints.
- To evaluate the feasibility of centralized production and distribution of an ACT product.
OUTLINE: This is a multicenter study. Patients are stratified according to the availability of multimer selection process. Patients are randomized to 1 of 3* treatment arms. Treatment begins 27 days after allogeneic hematopoietic stem cell transplantation.
NOTE: *Patients for whom multimer selection process is not available are randomize to arm A or arm B.
- Arm A (Standard best available antiviral drug therapy alone): Patients receive standard best available antiviral drug therapy comprising ganciclovir IV twice daily and oral valganciclovir twice daily with or without foscarnet IV twice daily on days 27, 34, 41, 48, 55, 62, 69, 76, 83, 90, 97, 111, 139, 167, and 197.
- Arm B (Adoptive cellular therapy [ACT] and standard best available antiviral drug therapy): Patients receive allogeneic CMV-specific T cells, prepared using Gamma Catch Selection, IV on day 27. They also receive standard best available antiviral drug therapy as in arm A.
- Arm C (ACT and standard best available antiviral drug therapy): Patients receive allogeneic CMV-specific T cells, prepared using Multimer Selection, IV on day 27. They also receive standard best available antiviral drug therapy as in arm A.
After completion of study therapy, patients are followed periodically.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Supportive Care
allogeneic cytomegalovirus pp65-specific cytotoxic T lymphocytes, allogeneic cytomegalovirus-specific cytotoxic T lymphocytes, foscarnet sodium, ganciclovir
UCL Cancer Institute
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:13:59-0400
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