Participant flow

Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation · Source last updated 2020-10-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.

   id

   FG000

   title

   Azacitidine/Donor Lymphocyte Infusion

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice