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NCT00578942 · FLOW

Participant flow

Allo Non-myeloablative SCT Utilizing Matched Family Member Stem Cells Purged Using Campath · Source last updated 2016-06-24

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 Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors 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. Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.
    id
    FG000
    title
    Campath Purged Non-myeloablative ASCT
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        47
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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 aspirate/biopsy. Subjects were premedicated with Benadryl and acetaminophen.
recruitment Details
This study was opened and first consent obtained on 9/11/2002 and was closed to accrual on 2/18/2008 as enrollment goal was met. Recruitment took place at Duke hospital in the Bone Marrow Transplant clinic during time of clinical appointments in a private location. Follow up for survival was discontinued in April 2013.
Complete source fields
groups
  1. description
    Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors 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. Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.
    id
    FG000
    title
    Campath Purged Non-myeloablative ASCT
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        48
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        47
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      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 aspirate/biopsy. Subjects were premedicated with Benadryl and acetaminophen.
recruitment Details
This study was opened and first consent obtained on 9/11/2002 and was closed to accrual on 2/18/2008 as enrollment goal was met. Recruitment took place at Duke hospital in the Bone Marrow Transplant clinic during time of clinical appointments in a private location. Follow up for survival was discontinued in April 2013.

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Preserved source evidence · Not medical advice