Participant flow

Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath · Source last updated 2014-06-03

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

groups

1. description

   Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously(dose will be rounded to the nearest whole vial size and may be divided into bid dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45.

   id

   FG000

   title

   Campath Purged Non-myeloablative ASCT

2. description

   Donor must be a sibling, half sibling, parent, child or first cousin familial relationship and 3-5/6 Human Leukocyte Antigen matched related to subject. They must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following: 1. Adequate cardiac function by history and physical examination 2. bilirubin and hepatic transaminases \< 2.5 x upper limit of normal 3. normal hematologic parameters Females should have a negative serum pregnancy test.

   id

   FG001

   title

   Donor Apheresis

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         0

      type

      Toxicity

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         88

      2. group Id

         FG001

         num Subjects

         88

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         88

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Prior to selecting a donor: donor and subjects had history and physical exam, labs and chest x-ray performed per program and FACT requirements. Female donors should have a negative pregnancy test. Subjects also had bone marrow. Prior to treatment, disease progression and insurance denial led to removal from the study.

recruitment Details

Recruitment began in February, 2003 and ended in February, 2008. Recruitment took place at Duke and Florida hospitals in the Bone Marrow Transplant clinics during time of clinical appointments in a private location.

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Preserved source evidence · Not medical advice