{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"33.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements.\n\n\"Chimerism\" in hematopoietic cell transplant derives from this idea of a \"mixed\" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.","groups":[{"description":"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG000","title":"Group 1A (Pentostatin, DLI Dose Level 1)"},{"description":"Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG001","title":"Group 1B (Pentostatin, DLI Dose Level 2)"},{"description":"Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG002","title":"Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)"},{"description":"Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.\n\nPentostatin: Given IV\n\nTherapeutic Allogeneic Lymphocytes: Given IV","id":"OG003","title":"Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)"}],"paramType":"NUMBER","populationDescription":"No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.","reportingStatus":"POSTED","timeFrame":"From the time of enrollment maintained to day 56 after the last DLI, up to Day 112","title":"Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism","type":"PRIMARY","unitOfMeasure":"percentage of participants"}