This phase II trial studies how well donor cytomegalovirus-specific cytotoxic T-lymphocytes work in treating patients with a cytomegalovirus infection that has come back or has not gotten better despite standard therapy. White blood cells from donors who have been exposed to cytomegalovirus may be effective in treating patients with a cytomegalovirus infection.
PRIMARY OBJECTIVE: I. To assess the efficacy, feasibility and safety of administering most closely human leukocyte antigen (HLA)-matched cytomegalovirus (CMV) specific cytotoxic T-lymphocytes (HMC-CTLs) generated by "gamma-catch" to mediate antiviral activity in hematopoietic stem cell transplantation (HSCT) recipients with CMV infections. SECONDARY OBJECTIVE: I. To assess the persistency of the administered HMC-CTLs generated by "gamma-catch" and their contribution immune reconstitution. OUTLINE: Patients receive allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes intravenously (IV). Patients with partial response, stable disease, or progressive disease may receive an additional dose of allogeneic cytomegalovirus-specific cytotoxic T-lymphocytes at a minimum of 2 weeks from the first infusion. After completion of study treatment, patients are followed up periodically for 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Given IV
M D Anderson Cancer Center
Houston, Texas, United States
Success, defined as R1 and R2 without treatment failure
The best outcome is defined as R1 = in complete response (CR) for 4 consecutive weeks, starting at week 2, without the need for a second cytotoxic T-lymphocyte (CTL) infusion. The second best outcome is defined as R2 = not in CR at week 2, 3, or 4, but in CR or partial response (PR) 4 weeks after the second CTL infusion.
Time frame: Up to 4 weeks after second CTL infusion
Overall survival time
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
Time frame: Up to 12 months
Disease-free survival time
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression. Unadjusted event time distributions will be estimated using the Kaplan-Meier method.
Time frame: Up to 12 months
Graft-versus-host disease
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression.
Time frame: Up to 12 months
Secondary graft failure
Will be analyzed as a function of patient covariates using standard statistical methods, including Bayesian survival regression analysis and ordinal regression.
Time frame: Up to 12 months
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