Participant flow

GVAX vs. Placebo for MDS/AML After Allo HSCT · Source last updated 2022-07-18

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

groups

1. description

   GVAX vaccine Participants in the GVAX vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. GVAX: GVAX vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.

   id

   FG000

   title

   GVAX

2. description

   Placebo vaccine Participants in the placebo vaccine arm will undergo a conditioning regimen with busulfan and fludarabine prior to allogeneic hematopoietic stem cell transplant. Immediately after allogeneic hematopoietic stem cell transplant participants will start tacrolimus and methotrexate to prevent GVHD. Conditioning regimen: In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 4 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan. Allogeneic Hematopoietic Stem Cell Transplant: Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. GVHD Prevention: * Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months. * Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant. Placebo: Placebo vaccination will begin between 30 to 45 days following participant's transplant, provided participant meets vaccination initiation criteria.

   id

   FG001

   title

   Placebo

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         64

      2. group Id

         FG001

         num Subjects

         59

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         30

      2. group Id

         FG001

         num Subjects

         27

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         34

      2. group Id

         FG001

         num Subjects

         32

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice