Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT00309842
Collaborator
(none)
213
Enrollment
2
Locations
1
Arm
171.8
Actual Duration (Months)
106.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Giving chemotherapy drugs, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil may stop this from happening.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing an umbilical cord blood transplant for hematologic cancer.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Determine the 1-year survival of patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine, cyclophosphamide, and fractionated total-body irradiation.

Secondary

  • Determine the incidence of transplant-related mortality at 6 months after UCBT.

  • Evaluate the pattern of chimerism after double UCBT.

  • Determine the incidence of neutrophil engraftment at day 42 after UCBT.

  • Determine the incidence of platelet engraftment at 6 months after UCBT.

  • Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT.

  • Determine the incidence of chronic GVHD at 1 year after UCBT.

  • Determine the disease-free survival at 1 and 2 years after UCBT.

  • Determine the incidence of relapse at 1 year after UCBT.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

  • Preparative Regimen: Patients receive fludarabine IV over 1 hour on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients also undergo total-body irradiation twice daily on days -4 to -1.

  • Umbilical Cord Blood Transplantation (UCBT): Patients undergo 1 or 2 units of UCBT on day 0. Patients receive filgrastim (G-CSF) IV once daily beginning on day 1 and continuing until blood counts recover.

  • Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours 2 or 3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. Patients also receive mycophenolate mofetil IV or orally 2 or 3 times a day beginning on day -3 and continuing until day 30 or 7 days after engraftment in the absence of acute GVHD.

After completion of study treatment, patients are followed periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
213 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transplantation of Unrelated Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen
Actual Study Start Date :
Jul 28, 2005
Actual Primary Completion Date :
Jul 29, 2019
Actual Study Completion Date :
Nov 22, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Unrelated UCBT for Blood Cancers

Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.

Biological: filgrastim
All patients will receive G-CSF 5 mcg/kg/day intravenously(IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days.
Other Names:
  • G-CSF
  • Drug: cyclophosphamide
    Cyclophosphamide to be administered with high volume fluid flush and mesna (MT(S) 9006) at 10:00am, or per institutional routine, on days-7 and -6 after fludarabine. Cyclophosphamide 60mg/kg/day intravenous (IV) x 2 days, total dose 120 mg/kg (days -7 and -6) Dosing is calculated based on Actual BodyWeight (ABW) unless ABW > 30 kg above Ideal BodyWeight (IBW), in which case the dose should be computed using adjusted body weight.
    Other Names:
  • Cytoxan
  • Drug: cyclosporine
    Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of > 200 ng/mL. For adults the initial dose will be 2.5 mg/kg intravenously (IV) over 2 hours every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 2 hours every 8 hours.
    Other Names:
  • CSA
  • Drug: fludarabine phosphate
    Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -8 to -6);
    Other Names:
  • Fludara
  • Drug: mycophenolate mofetil
    All patients will begin mycophenolate mofetil (MMF) on day -3. Patients ≥ 40 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses (every 12 or 8 hours). Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg three times a day.
    Other Names:
  • MMF
  • Procedure: umbilical cord blood transplantation
    The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.
    Other Names:
  • UCBT
  • Radiation: total-body irradiation
    The recommended TBI is 165 cGy given twice daily for a total dose of 1320 cGy (days -4 to -1).
    Other Names:
  • TBI
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Were Alive at 1 Year Transplant Overall Survival [at 1 year]

      Number of patients alive at 1 year after transplant.

    Secondary Outcome Measures

    1. Number of Participants Who Died Due to Transplant [At Month 6]

      Determine the incidence of transplant-related mortality at 6 months after UCBT

    2. Number of Participants With Platelet Engraftment [6 months]

      Determine the incidence of platelet engraftment (platelet recovery >50,000/uL) at 6 months after UCBT.

    3. Number of Participants With Neutrophil Engraftment [Day 42]

      Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC > 5 x 10^8/L of donor origin by day +42)

    4. Number of Participants With Acute Graft-Versus-Host Disease [Day 100]

      Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

    5. Number of Participants With Chronic Graft-Versus-Host Disease [Year 1]

      Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

    6. Percentage Chimerism on Day 21 [Day 21]

      Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.

    7. Percentage Chimerism on Day 100 [Day 100]

      Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.

    8. Percentage Chimerism at 6 Months [Month 6]

      Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.

    9. Percentage Chimerism at 1 Year [1 Year]

      Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.

    10. Percentage Chimerism at 2 Years [2 Years]

      Chimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Acute myeloid leukemia (AML): high risk CR1 (as evidenced by preceding myelodysplastic syndrome [MDS], high risk cytogenetics, ≥ 2 cycles to obtain complete remission [CR], erythroblastic or megakaryocytic leukemia; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.

    • Very high risk pediatric patients with AML. Patients <21 years, however, are eligible with (M2 marrow) with < or = 25% blasts in marrow after having failed one or more cycles of chemotherapy. This group of patients will be analyzed separately.

    • Acute lymphocytic leukemia (ALL): high risk CR1 [t(9;22), t (1:19), t(4;11) or other MLL rearrangements] hypodiploidy, or IKZF1 abnormalities), DNA index < 0.81, > 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.

    • Very high risk pediatric patients with ALL. patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission

    • Chronic myelogenous leukemia (CML) excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.

    • Plasma Cell leukemia after initial therapy, who achieved at least a partial remission

    • Advanced myelofibrosis

    • Myelodysplasia (MDS) IPSS Int-2 or High risk (i.e. RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics. Blasts must be < 10% by a representative bone marrow aspirate morphology.

    • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.

    • Lymphoplasmacytic lymphoma, mantle-cell lymphoma, prolymphocytic leukemia are eligible after initial therapy in CR1+ or PR1+.

    • Large cell NHL > CR2/> PR2. Patients in CR2/PR2 with initial short remission (<6 months) are eligible.

    • Lymphoblastic lymphoma, Burkitt's lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year.

    • Multiple myeloma beyond PR2. Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy.

    • Recipients must have a Karnofsky score (adults) ≥ 80 % or Lansky score ≥ 50% (pediatrics), and proper organ function.

    Exclusion Criteria

    • Active infection at time of transplantation

    • History of human immunodeficiency virus (HIV) infection

    • Pregnant or breast feeding.

    • Chemotherapy refractory large cell and high grade NHL

    • If < or = 18 years old, prior myeloablative transplant within the last 6 months. If

    18 years old prior myeloablative allotransplant or autologous transplant

    • Extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation.

    • Patients who have received Y-90 ibritumomab (Zevalin) or I-131 tostumomab (Bexxar), as part of their salvage therapy.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Masonic Cancer Center at University of MinnesotaMinneapolisMinnesotaUnited States55455
    2Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States98109

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Study Chair: Claudio G. Brunstein, MD, PhD, 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:
    NCT00309842
    Other Study ID Numbers:
    • 2005LS043
    • UMN-MT2005-10
    • UMN-0507M71475
    First Posted:
    Apr 3, 2006
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Period Title: Overall Study
    STARTED213
    COMPLETED212
    NOT COMPLETED1

    Baseline Characteristics

    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Overall Participants212
    Age (Count of Participants)
    <=18 years
    76
    35.8%
    Between 18 and 65 years
    136
    64.2%
    >=65 years
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    96
    45.3%
    Male
    116
    54.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    13
    6.1%
    Not Hispanic or Latino
    199
    93.9%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    13
    6.1%
    Native Hawaiian or Other Pacific Islander
    3
    1.4%
    Black or African American
    12
    5.7%
    White
    162
    76.4%
    More than one race
    6
    2.8%
    Unknown or Not Reported
    16
    7.5%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants Who Were Alive at 1 Year Transplant Overall Survival
    DescriptionNumber of patients alive at 1 year after transplant.
    Time Frameat 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Count of Participants [Participants]
    130
    61.3%
    2. Secondary Outcome
    TitleNumber of Participants Who Died Due to Transplant
    DescriptionDetermine the incidence of transplant-related mortality at 6 months after UCBT
    Time FrameAt Month 6

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Count of Participants [Participants]
    58
    27.4%
    3. Secondary Outcome
    TitleNumber of Participants With Platelet Engraftment
    DescriptionDetermine the incidence of platelet engraftment (platelet recovery >50,000/uL) at 6 months after UCBT.
    Time Frame6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Count of Participants [Participants]
    159
    75%
    4. Secondary Outcome
    TitleNumber of Participants With Neutrophil Engraftment
    DescriptionDetermine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC > 5 x 10^8/L of donor origin by day +42)
    Time FrameDay 42

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Count of Participants [Participants]
    21
    9.9%
    5. Secondary Outcome
    TitleNumber of Participants With Acute Graft-Versus-Host Disease
    DescriptionDetermine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
    Time FrameDay 100

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Grade II-IV
    106
    50%
    Grade III-IV
    49
    23.1%
    6. Secondary Outcome
    TitleNumber of Participants With Chronic Graft-Versus-Host Disease
    DescriptionDetermine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
    Time FrameYear 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Count of Participants [Participants]
    39
    18.4%
    7. Secondary Outcome
    TitlePercentage Chimerism on Day 21
    DescriptionChimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.
    Time FrameDay 21

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Mean (Standard Deviation) [percentage of donor cells]
    92.6
    (14.9)
    8. Secondary Outcome
    TitlePercentage Chimerism on Day 100
    DescriptionChimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.
    Time FrameDay 100

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Mean (Standard Deviation) [percentage of donor cells]
    98.1
    (8.5)
    9. Secondary Outcome
    TitlePercentage Chimerism at 6 Months
    DescriptionChimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.
    Time FrameMonth 6

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Mean (Standard Deviation) [percentage of donor cells]
    98.1
    (11.3)
    10. Secondary Outcome
    TitlePercentage Chimerism at 1 Year
    DescriptionChimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.
    Time Frame1 Year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Mean (Standard Deviation) [percentage of donor cells]
    99.1
    (8.5)
    11. Secondary Outcome
    TitlePercentage Chimerism at 2 Years
    DescriptionChimerism studies will be performed on the bone marrow on days 21 and 100 and at 6 months, 1 year and 2 years. In cases of slow engraftment a bone marrow biopsy may be repeated on day +28.
    Time Frame2 Years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    Measure Participants212
    Mean (Standard Deviation) [percentage of donor cells]
    100
    (0.1)

    Adverse Events

    Time FrameUpto 2 years
    Adverse Event Reporting Description
    Arm/Group TitleUnrelated UCBT for Blood Cancers
    Arm/Group DescriptionPatients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
    All Cause Mortality
    Unrelated UCBT for Blood Cancers
    Affected / at Risk (%)# Events
    Total161/212 (75.9%)
    Serious Adverse Events
    Unrelated UCBT for Blood Cancers
    Affected / at Risk (%)# Events
    Total92/212 (43.4%)
    Blood and lymphatic system disorders
    Thrombocytopenia1/212 (0.5%) 1
    Cardiac disorders
    cardiopulmonary arrest1/212 (0.5%) 1
    Hepatobiliary disorders
    Veno-Occlusive Disease (VOD)1/212 (0.5%) 1
    Immune system disorders
    Graft versus host disease (GVHD)13/212 (6.1%) 13
    Infections and infestations
    Infection10/212 (4.7%) 11
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Death41/212 (19.3%) 41
    Graft failure9/212 (4.2%) 9
    Progressive disease1/212 (0.5%) 1
    relapse7/212 (3.3%) 7
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome (ARDS)4/212 (1.9%) 4
    Pulmonary hemorrage1/212 (0.5%) 1
    Pulmonary other3/212 (1.4%) 3
    Other (Not Including Serious) Adverse Events
    Unrelated UCBT for Blood Cancers
    Affected / at Risk (%)# Events
    Total187/212 (88.2%)
    Blood and lymphatic system disorders
    Hemorrhage12/212 (5.7%) 14
    Cardiac disorders
    Pericardial effusion46/212 (21.7%) 52
    Gastrointestinal disorders
    GI bleeding18/212 (8.5%) 19
    General disorders
    Multi organ failure12/212 (5.7%) 13
    Engraftment syndrome25/212 (11.8%) 25
    Hepatobiliary disorders
    Veno-Occlusive Disease (VOD)12/212 (5.7%) 19
    Infections and infestations
    Infection126/212 (59.4%) 527
    Metabolism and nutrition disorders
    Hyperglycemia22/212 (10.4%) 22
    Nervous system disorders
    Neurotoxicity13/212 (6.1%) 14
    Neuropathy16/212 (7.5%) 16
    Renal and urinary disorders
    Acute kidney injury18/212 (8.5%) 18
    Dialysis23/212 (10.8%) 23
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome (ARDS)26/212 (12.3%) 27
    Pulmonary hemorrhage34/212 (16%) 42
    Intubation58/212 (27.4%) 74
    Pneumonia131/212 (61.8%) 297
    Vascular disorders
    Hypertension62/212 (29.2%) 62

    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/TitleDr.Claudio G. Brunstein MD, PhD
    OrganizationMasonic Cancer Center, University of Minnesota
    Phone612-625-3918
    Emailbruns072@umn.edu
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00309842
    Other Study ID Numbers:
    • 2005LS043
    • UMN-MT2005-10
    • UMN-0507M71475
    First Posted:
    Apr 3, 2006
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020