Busulfan and Cyclophosphamide Followed By ALLO BMT

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Terminated
CT.gov ID
NCT01685411
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
85.3
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a treatment guideline to allow routine clinical data to be collected and maintained in Oncore (clinical database) and the University of Minnesota Blood and Marrow Database as part of the historical database maintained by the department.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Detailed Description

This is a single arm trial to evaluate the efficacy of busulfan and cyclophosphamide followed by an allogeneic hematopoietic stem cell transplant (HSCT) in the treatment of hematological malignancies. The intent of this study is to provide a protocol that will use unmanipulated allogeneic hematopoietic stem cells from related and unrelated donors after a common preparative regimen.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Busulfan and Cyclophosphamide Followed By Allogeneic Hematopoietic Cell Transplantation In Patients With Hematological Malignancies
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Feb 10, 2020
Actual Study Completion Date :
Feb 10, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Allogeneic Hematopoietic Stem Cell Transplant

Patients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.

Drug: Allopurinol
Day -8 (prior to transplant): Per institutional guidelines
Other Names:
  • Lopurin
  • Zyloprim
  • Drug: Keppra
    Day -8 (prior to transplant): Per institutional guidelines
    Other Names:
  • Levetiracetam
  • Drug: Busulfan
    Days -7 through -4 (prior to transplant): given intravenously (IV) infusion over 2 hours every 6 hours following dose, administration and pharmacokinetic monitoring per University of Minnesota institutional guidelines.
    Other Names:
  • Myleran
  • Drug: Cyclophosphamide
    Days -3 and -2 (prior to transplantation): given as a 2 hour intravenous infusion with a high volume fluid flush and mesna per institutional guidelines. Dosing is based on actual body weight.
    Other Names:
  • Cytoxan
  • Drug: Tacrolimus
    All patients (regardless of allograft source) will receive tacrolimus therapy beginning on day -3. Dosing will be monitored and altered as clinically appropriate per institutional pharmacy guidelines. Dose adjustments will be made on the basis of toxicity and/or low tacrolimus levels. Taper at day +100 for matched sibling donor (MSD) recipients, and day +180 for non-MSD recipients. Taper to zero by 10% weekly dose reduction over approximately 10 weeks.

    Drug: Mycophenolate mofetil
    Day -3 (prior to transplant): Recipients of umbilical cord blood will given a dose of 3 gm/day every 8 or 12 hours (> or = 40 kg) or 15 mg/kg 3 times per day (< 40 kg) for up to 30 days unless no engraftment.
    Other Names:
  • MMF
  • Biological: Allogeneic hematopoietic stem cell transplant
    Day 0 (or Day+1/+2 to accommodate weekdays): Infusion of cells from related or unrelated donor bone marrow or single or double unrelated donor umbilical cord blood.

    Biological: Filgrastim
    Beginning Day +1: Intravenously (IV) 5 mcg/kg once daily and continuing until the absolute neutrophil count is >2500 x 10^9/L or per institutional guidelines.
    Other Names:
  • G-CSF
  • Granulocyte-colony stimulating factor
  • Biological: antithymocyte globulin
    Administered per institutional guidelines for recipients of umbilical cord blood transplant.
    Other Names:
  • ATG
  • Outcome Measures

    Primary Outcome Measures

    1. Counts of Participants With Disease Free Survival [2 Years]

      The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    2. Count of Participants With Disease Free Survival [5 Years]

      The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    3. Count of Participants With Disease Free Survival [7 Years]

      The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    Secondary Outcome Measures

    1. Count of Participants Who Achieved Neutrophil Engraftment [By Day 42]

      Neutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater.

    2. Percentage of Participants With Acute Graft-Versus-Host Disease by Grade [Day 100]

      Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.

    3. Percentage of Participants With Chronic Graft-Versus-Host Disease [6 Months]

      Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.

    4. Percentage of Participants With Chronic Graft-Versus-Host Disease [1 Year]

      Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.

    5. Percentage of Participants With Treatment-Related Toxicity [6 Months]

      In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.

    6. Percentage of Participants With Treatment-Related Toxicity [1 year]

      In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.

    7. Percentage of Participants With Relapse [1 Year]

      The return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    8. Percentage of Participants With Relapse [2 Years]

      The return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.

    9. Percentage of Participants With Engraftment Failure [Day 42]

      Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.

    10. Number of Participant Who Were Alive at 2 Years Post Transplant [2 Years]

      Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.

    11. Number of Participant Who Were Alive at 5 Years Post Transplant [5 Years]

      Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.

    12. Number of Participant Who Were Alive at 7 Years Post Transplant [7 Years]

      Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 44 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and current in complete remission meeting one of the following:

    • <45 years of age who are at least 6 months after initial hematopoietic stem cell transplant (HSCT)

    • <45 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy

    • Karnofsky performance status >70% or if <16 years of age, a Lansky play score >50

    • Adequate major organ function including:

    • cardiac: left ventricular ejection fraction >45% by echocardiogram (ECHO/MUGA)

    • renal: creatinine clearance >40 mL/min/1.73m^2

    • hepatic: no clinical evidence of hepatic failure (e.g., coagulopathy, ascites)

    • An acceptable source of stem cells according to current University of Minnesota Bone

    Marrow Transplant program guidelines. Acceptable stem cell sources include:
    • HLA-matched related or unrelated donor bone marrow (6/6 or 5/6 antigen match)

    • HLA-matched related or unrelated donor peripheral blood stem cells

    • related or single or double unrelated donor umbilical cord blood (6/6, 5/6 or 4/6 match)

    • Women of childbearing age must have a negative pregnancy test and all sexually active participants must agree to use effective contraception during study treatment

    • Written consent (adult or parent/guardian)

    Exclusion Criteria:
    • eligible for TBI containing preparative regimen

    • active uncontrolled infection within one week of study enrollment

    • pregnant or lactating female

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Masonic Cancer Center, University of MinnesotaMinneapolisMinnesotaUnited States55455

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Principal Investigator: Margaret L. MacMillan, M.D., Masonic Cancer Center, University of Minnesota

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01685411
    Other Study ID Numbers:
    • 2011OC139
    • MT2011-20C
    First Posted:
    Sep 14, 2012
    Last Update Posted:
    Apr 13, 2021
    Last Verified:
    Mar 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Period Title: Overall Study
    STARTED5
    COMPLETED5
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion
    Overall Participants5
    Age (Count of Participants)
    <=18 years
    5
    100%
    Between 18 and 65 years
    0
    0%
    >=65 years
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    2
    40%
    Male
    3
    60%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    5
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    5
    100%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    5
    100%

    Outcome Measures

    1. Primary Outcome
    TitleCounts of Participants With Disease Free Survival
    DescriptionThe length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time Frame2 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Count of Participants [Participants]
    3
    60%
    2. Primary Outcome
    TitleCount of Participants With Disease Free Survival
    DescriptionThe length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time Frame5 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Count of Participants [Participants]
    1
    20%
    3. Primary Outcome
    TitleCount of Participants With Disease Free Survival
    DescriptionThe length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. Patients with leukemia involving the BM and myelodysplastic syndrome will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time Frame7 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Count of Participants [Participants]
    1
    20%
    4. Secondary Outcome
    TitleCount of Participants Who Achieved Neutrophil Engraftment
    DescriptionNeutrophil engraftment is defined as the first day of three consecutive days where the neutrophil count (absolute neutrophil count) is 500 cells/mm^3 (0.5 x 10^9/L) or greater.
    Time FrameBy Day 42

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Count of Participants [Participants]
    5
    100%
    5. Secondary Outcome
    TitlePercentage of Participants With Acute Graft-Versus-Host Disease by Grade
    DescriptionAcute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.
    Time FrameDay 100

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Grade 2-4
    40
    800%
    Grade 3-4
    20
    400%
    6. Secondary Outcome
    TitlePercentage of Participants With Chronic Graft-Versus-Host Disease
    DescriptionChronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.
    Time Frame6 Months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    7. Secondary Outcome
    TitlePercentage of Participants With Chronic Graft-Versus-Host Disease
    DescriptionChronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria used for staging. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level. The stages of individual organ involvement are combined to produce an overall grade. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.
    Time Frame1 Year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    8. Secondary Outcome
    TitlePercentage of Participants With Treatment-Related Toxicity
    DescriptionIn the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
    Time Frame6 Months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    9. Secondary Outcome
    TitlePercentage of Participants With Treatment-Related Toxicity
    DescriptionIn the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.
    Time Frame1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    10. Secondary Outcome
    TitlePercentage of Participants With Relapse
    DescriptionThe return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time Frame1 Year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Number (95% Confidence Interval) [percentage of participants]
    40
    800%
    11. Secondary Outcome
    TitlePercentage of Participants With Relapse
    DescriptionThe return of disease after its apparent recovery/cessation. Patients with leukemia involving the BM and myelodysplastic syndrome will have this assessed by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients will also have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated.
    Time Frame2 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Number (95% Confidence Interval) [percentage of participants]
    40
    800%
    12. Secondary Outcome
    TitlePercentage of Participants With Engraftment Failure
    DescriptionGraft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
    Time FrameDay 42

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    13. Secondary Outcome
    TitleNumber of Participant Who Were Alive at 2 Years Post Transplant
    DescriptionOverall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.
    Time Frame2 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Count of Participants [Participants]
    4
    80%
    14. Secondary Outcome
    TitleNumber of Participant Who Were Alive at 5 Years Post Transplant
    DescriptionOverall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.
    Time Frame5 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Count of Participants [Participants]
    3
    60%
    15. Secondary Outcome
    TitleNumber of Participant Who Were Alive at 7 Years Post Transplant
    DescriptionOverall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive.
    Time Frame7 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    Measure Participants5
    Count of Participants [Participants]
    1
    20%

    Adverse Events

    Time Frame7 years
    Adverse Event Reporting Description
    Arm/Group TitleAllogeneic Hematopoietic Stem Cell Transplant
    Arm/Group DescriptionPatients treated with Allopurinol, Keppra, Busulfan, Cyclophosphamide, Filgrastim, antithymocyte globulin, Tacrolimus, Mycophenolate mofetil and allogeneic hematopoietic stem cell transplant infusion.
    All Cause Mortality
    Allogeneic Hematopoietic Stem Cell Transplant
    Affected / at Risk (%)# Events
    Total4/5 (80%)
    Serious Adverse Events
    Allogeneic Hematopoietic Stem Cell Transplant
    Affected / at Risk (%)# Events
    Total0/5 (0%)
    Other (Not Including Serious) Adverse Events
    Allogeneic Hematopoietic Stem Cell Transplant
    Affected / at Risk (%)# Events
    Total5/5 (100%)
    Blood and lymphatic system disorders
    CSA induced hypertension2/5 (40%) 2
    Transplant-associated thrombotic microangiopathy1/5 (20%) 1
    Cardiac disorders
    Cardiac dysfunction1/5 (20%) 1
    Pericardial effusion1/5 (20%) 1
    Endocrine disorders
    Adrenal insufficiency1/5 (20%) 1
    Eye disorders
    Cataracts1/5 (20%) 1
    Gastrointestinal disorders
    Ascites1/5 (20%) 1
    GI bleeding1/5 (20%) 1
    General disorders
    Engraftment syndrome1/5 (20%) 1
    Infections and infestations
    Bacterial infection4/5 (80%) 26
    Fungal infection1/5 (20%) 3
    Pneumonia3/5 (60%) 6
    Viral infection2/5 (40%) 11
    Metabolism and nutrition disorders
    Hyperglycemia1/5 (20%) 1
    Musculoskeletal and connective tissue disorders
    Osteopenia1/5 (20%) 1
    Nervous system disorders
    Brain infarction1/5 (20%) 1
    Multifactorial delirium1/5 (20%) 1
    Neurotoxicity1/5 (20%) 2
    Seizure1/5 (20%) 1
    Renal and urinary disorders
    Renal failure1/5 (20%) 2
    Respiratory, thoracic and mediastinal disorders
    Veno-occlusive disease (VOD)1/5 (20%) 1
    Intubation1/5 (20%) 3
    Respiratory failure1/5 (20%) 1
    Shortness of breath1/5 (20%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleMargaret L. MacMillan, M.D.
    OrganizationMasonic Cancer Center, University of Minnesota
    Phone612-626-2778
    Emailmacmi002@umn.edu
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01685411
    Other Study ID Numbers:
    • 2011OC139
    • MT2011-20C
    First Posted:
    Sep 14, 2012
    Last Update Posted:
    Apr 13, 2021
    Last Verified:
    Mar 1, 2021