Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transp… (NCT00769613) | Clinical Trial Compass
UnknownPhase 1
Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
United States20 participantsStarted 2008-08
Plain-language summary
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus.
PURPOSE: This phase I trial is studying how well cytotoxic T cells work in treating patients who have undergone donor stem cell transplant and have cytomegalovirus infections.
Who can participate
Age range2 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Recipient of an allogeneic stem cell transplantation
* Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria:
* Patient has a history of CMV antigenemia for ≥ 2 weeks
* CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet)
* No ongoing graft-vs-host disease
* Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria:
* CMV-seropositive donor (≥ 2 years of age)
* CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients \< 16 years of age)
* Bilirubin \< 2.0 mg/dL
* AST and ALT \< 2.5 times normal
* Creatinine clearance ≥ 30 mL/min
* Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask
* Not moribund
* No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion