Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00281879 · BASELINE

Baseline characteristics

Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer · Source last updated 2017-09-27

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

denoms
  1. counts
    1. group Id
      BG000
      value
      128
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      0
    8. group Id
      BG007
      value
      1
    9. group Id
      BG008
      value
      200
    units
    Participants
groups
  1. description
    On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
    id
    BG000
    title
    Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)
  2. description
    On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
    id
    BG001
    title
    Busulfan and Cyclophosphamide (Cytoxan)
  3. description
    On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
    id
    BG002
    title
    BEAM Regimen
  4. description
    A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
    id
    BG003
    title
    Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)
  5. description
    On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
    id
    BG004
    title
    Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)
  6. description
    If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
    id
    BG005
    title
    ATG For Cord Blood Transplants
  7. description
    Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
    id
    BG006
    title
    DLI (Donor Leukocyte Infusion)
  8. description
    On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
    id
    BG007
    title
    Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          7
        6. group Id
          BG007
          value
          1
        7. group Id
          BG008
          value
          42
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          20
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG007
          value
          0
        7. group Id
          BG008
          value
          156
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          2
        6. group Id
          BG007
          value
          0
        7. group Id
          BG008
          value
          2
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.923
          value
          32.033
        2. group Id
          BG001
          spread
          11.67
          value
          48.33
        3. group Id
          BG002
          spread
          12.87
          value
          46.187
        4. group Id
          BG004
          spread
          7.90
          value
          12.22
        5. group Id
          BG005
          spread
          10.725
          value
          11.77
        6. group Id
          BG007
          spread
          0
          value
          5.42
        7. group Id
          BG008
          spread
          16.818
          value
          34.743
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG004
          value
          4
        5. group Id
          BG005
          value
          5
        6. group Id
          BG007
          value
          1
        7. group Id
          BG008
          value
          82
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          17
        4. group Id
          BG004
          value
          2
        5. group Id
          BG005
          value
          4
        6. group Id
          BG007
          value
          0
        7. group Id
          BG008
          value
          118
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          20
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          9
        6. group Id
          BG007
          value
          1
        7. group Id
          BG008
          value
          200
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      128
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      0
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      0
    8. group Id
      BG007
      value
      1
    9. group Id
      BG008
      value
      200
    units
    Participants
groups
  1. description
    On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
    id
    BG000
    title
    Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)
  2. description
    On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
    id
    BG001
    title
    Busulfan and Cyclophosphamide (Cytoxan)
  3. description
    On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
    id
    BG002
    title
    BEAM Regimen
  4. description
    A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
    id
    BG003
    title
    Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)
  5. description
    On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
    id
    BG004
    title
    Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)
  6. description
    If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
    id
    BG005
    title
    ATG For Cord Blood Transplants
  7. description
    Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
    id
    BG006
    title
    DLI (Donor Leukocyte Infusion)
  8. description
    On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
    id
    BG007
    title
    Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)
  9. description
    Total of all reporting groups
    id
    BG008
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          7
        6. group Id
          BG007
          value
          1
        7. group Id
          BG008
          value
          42
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          20
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          0
        6. group Id
          BG007
          value
          0
        7. group Id
          BG008
          value
          156
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG004
          value
          0
        5. group Id
          BG005
          value
          2
        6. group Id
          BG007
          value
          0
        7. group Id
          BG008
          value
          2
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.923
          value
          32.033
        2. group Id
          BG001
          spread
          11.67
          value
          48.33
        3. group Id
          BG002
          spread
          12.87
          value
          46.187
        4. group Id
          BG004
          spread
          7.90
          value
          12.22
        5. group Id
          BG005
          spread
          10.725
          value
          11.77
        6. group Id
          BG007
          spread
          0
          value
          5.42
        7. group Id
          BG008
          spread
          16.818
          value
          34.743
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG004
          value
          4
        5. group Id
          BG005
          value
          5
        6. group Id
          BG007
          value
          1
        7. group Id
          BG008
          value
          82
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          17
        4. group Id
          BG004
          value
          2
        5. group Id
          BG005
          value
          4
        6. group Id
          BG007
          value
          0
        7. group Id
          BG008
          value
          118
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          20
        4. group Id
          BG004
          value
          6
        5. group Id
          BG005
          value
          9
        6. group Id
          BG007
          value
          1
        7. group Id
          BG008
          value
          200
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice