Participant flow

Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers · Source last updated 2018-12-31

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

groups

1. description

   Patients receive low intensity fludarabine phosphate intravenous (IV) and cyclophosphamide IV on days -6 to -3. Patients undergo donor lymphocyte infusion (DLI) with sirolimus generated donor T-helper 2 (Th2) cells on day 14 (single T-Rapa cell DLI in patients with cluster of differentiation 4 (CD4) count between 100 and 200 inclusive). Etoposide: Etoposide: 50 mg/m(2)/day continuous intravenous (CIV), days 1-4 Doxorubicin: Doxorubicin:10 mg/m(2)/day CIV, days 1-4 Vincristine: Vincristine:0.4 mg/m(2)/day CIV, days 1-4 Cyclophosphamide: Cyclophosphamide, 750 mg/m(2)/day IV, day 5 T cell donor lymphocyte infusion (DLI) with sirolimus generated donor TH-2 cells: The cell of the Th2 cells will attempt to be held constant for each study receipient (target dose 2.5 x 107 Th2/kg; minimum dose will be 1 x 107 Th2/kg).

   id

   FG000

   title

   Arm IVD Cohort 1 (Th2 DLI)

2. description

   Patients with nonlymphoma diagnosis or rapidly progressive lymphoma undergo DLI with multiple infusions of sirolimus generated donor Th2 cells beginning on day 14 (multiple T-Rapa cell DLI in patients with CD4 count lower than 100 or ALC lower than 300).

   id

   FG001

   title

   Arm IVD Cohort 3 (Multiple Th2 DLI)

3. description

   Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine by mouth twice a day (PO BID) on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic peripheral blood stem cells (PBSC) on day 0. Patients undergo DLI with 12-day expanded sirolimus-generated donor Th2 cells on day 14.

   id

   FG002

   title

   Arm IVA (12-day Expanded Th2 DLI)

4. description

   Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -4 to 100, and standard dose sirolimus PO on days -2 to 14. Patients undergo mobilized allogeneic PBSC or bone marrow transplant on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.

   id

   FG003

   title

   Arm IVB (6-day Expanded Th2 DLI)

5. description

   Patients receive low-intensity preparative chemotherapy with fludarabine phosphate IV and cyclophosphamide IV on days -6 to -3, cyclosporine PO BID on days -7 to 100 and high dose sirolimus PO on days -4 to 7, Patients undergo mobilized allogeneic PBSC on day 0. Patients undergo DLI with 6-day expanded sirolimus-generated donor Th2 cells on day 14.

   id

   FG004

   title

   Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus)

6. description

   Donate donor immune cells for recipients. No data was collected from the donor population.

   id

   FG005

   title

   Healthy Donors

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         0

      type

      Progressive malignancy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         34

      3. group Id

         FG002

         num Subjects

         40

      4. group Id

         FG003

         num Subjects

         44

      5. group Id

         FG004

         num Subjects

         45

      6. group Id

         FG005

         num Subjects

         221

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         27

      3. group Id

         FG002

         num Subjects

         40

      4. group Id

         FG003

         num Subjects

         44

      5. group Id

         FG004

         num Subjects

         42

      6. group Id

         FG005

         num Subjects

         221

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Enrollment was 442 (221 donors; 221 patients). 57 recipients were treated on cohorts no longer in the protocol due to amendments. Thus, 164 of 221 recipient data is presented. No patients were eligible for therapy on arm IVD, cohort 2.

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Preserved source evidence · Not medical advice