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Efficacy Study of T Cell Depleted Allogeneic Non-myeloablative Stem Cell Transplant · Source last updated 2014-06-02

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

groups
  1. description
    Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    FG000
    title
    Cohort A - Lymphoid Disease
  2. description
    Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    FG001
    title
    Cohort B - Myeloid Disease
  3. description
    1. 5-6/6 matched sibling who meets the other donor criteria is the first choice, 2. Matched Unrelated Donor (MUD) is the second choice\*, and 3. 3-5/6 partially matched family member (if 5/6 then this donor is not a sibling as that would be first choice) is the third choice for donor type. Multiple choices for 3-5/6 human leukocyte antigen (HLA) matched family member donors order of choice will be best match, then cytomegalovirus (CMV) negativity, then Killer-cell immunoglobulin-like receptors (KIR) mismatching (for natural killer \[NK\] cell activity), then history of pregnancy. All subjects without an available matched sibling must have a donor search initiated with the national bank. If potential high resolution matches are found but not utilized, the reason for proceeding with a partially matched family member should be documented (i.e. donor not available, not enough time to allow MUD donor work up and collection due to high risk nature of the subject's disease, etc).
    id
    FG002
    title
    Donor
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      type
      Recipient death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        94
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        84
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Recipients had history and exam, labs, x-ray, and possible bone marrow aspirate. Radiation therapy may be used prior to transplant for minimal active disease. Donor selection included a 5-6/6 matched sibling as the first choice, a matched unrelated donor as the second choice, or a 3-5/6 partially matched family member as the third choice.
recruitment Details
170 transplant recipients were recruited through the Adult Bone Marrow Transplant Program at Duke University Medical Center. Recruitment began in February, 2008 and ended in June, 2013. 33 recipients were screen failures. 94 donors were consented for leukapheresis.
Complete source fields
groups
  1. description
    Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    FG000
    title
    Cohort A - Lymphoid Disease
  2. description
    Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells \> 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
    id
    FG001
    title
    Cohort B - Myeloid Disease
  3. description
    1. 5-6/6 matched sibling who meets the other donor criteria is the first choice, 2. Matched Unrelated Donor (MUD) is the second choice\*, and 3. 3-5/6 partially matched family member (if 5/6 then this donor is not a sibling as that would be first choice) is the third choice for donor type. Multiple choices for 3-5/6 human leukocyte antigen (HLA) matched family member donors order of choice will be best match, then cytomegalovirus (CMV) negativity, then Killer-cell immunoglobulin-like receptors (KIR) mismatching (for natural killer \[NK\] cell activity), then history of pregnancy. All subjects without an available matched sibling must have a donor search initiated with the national bank. If potential high resolution matches are found but not utilized, the reason for proceeding with a partially matched family member should be documented (i.e. donor not available, not enough time to allow MUD donor work up and collection due to high risk nature of the subject's disease, etc).
    id
    FG002
    title
    Donor
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        10
      type
      Recipient death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        57
      3. group Id
        FG002
        num Subjects
        94
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        84
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        56
      2. group Id
        FG001
        num Subjects
        46
      3. group Id
        FG002
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Recipients had history and exam, labs, x-ray, and possible bone marrow aspirate. Radiation therapy may be used prior to transplant for minimal active disease. Donor selection included a 5-6/6 matched sibling as the first choice, a matched unrelated donor as the second choice, or a 3-5/6 partially matched family member as the third choice.
recruitment Details
170 transplant recipients were recruited through the Adult Bone Marrow Transplant Program at Duke University Medical Center. Recruitment began in February, 2008 and ended in June, 2013. 33 recipients were screen failures. 94 donors were consented for leukapheresis.

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Preserved source evidence · Not medical advice