Participant flow

Planned Donor Lymphocyte Infusion (DLI) After Allogeneic Stem Cell Transplantation (SCT) · Source last updated 2016-03-17

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

groups

1. description

   Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.

   id

   FG000

   title

   Stem Cell Infusion

2. description

   Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1\*10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\*10/L for 3 consecutive days.

   id

   FG001

   title

   Low Dose Donor T-Cells

3. description

   Fludarabine 40 mg/m\^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m\^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3\*10\^6 CD3+ cells/kg between Day +56 \& +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m\^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)\> 500\*10/L for 3 consecutive days.

   id

   FG002

   title

   High Dose Donor T-Cells

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Active graft-vs-host disease (GvHD)

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Secondary graft failure

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Stem Cell Transplant

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         3

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Donor Lymphocyte Infusion

pre Assignment Details

Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned Donor Lymphocyte Infusion (DLI). 9 participants did not meet the criteria to receive randomized planned DLI.

recruitment Details

Recruitment Period: February 6, 2012 to February 27, 2014. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

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Preserved source evidence · Not medical advice