Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers.

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Terminated
CT.gov ID
NCT00354172
Collaborator
(none)
16
Enrollment
1
Location
1
Arm
30
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Giving chemotherapy, natural killer cells, aldesleukin, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells and cancer cells. It also helps stop the patient's immune system from rejecting the donor's 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, mycophenolate mofetil, and methylprednisolone before and after transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation followed by donor umbilical cord blood natural killer cells, aldesleukin, and umbilical cord blood transplant works in treating patients with refractory hematologic cancer or other diseases.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

OBJECTIVES:

Primary

  • Determine the incidence of 6-month disease free survival. The primary laboratory objective is the measure of in vivo expansion of umbilical cord blood (UCB) derived natural killer cells (NK) after a fully ablative preparative regimen.

Secondary

  • Determine the incidence of transplant-related mortality at 6 months after NK UCB + double UCBT

  • Evaluate the pattern of chimerism after NK UCB + double UCBT

  • Determine the incidence of neutrophil engraftment at day 42 after NK UCB + double umbilical cord blood transplantation (UCBT)

  • Determine the incidence of platelet engraftment at 6 months after NK UCB + double UCBT

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

  • Determine the incidence of chronic GVHD at 1 year after NK UCB + double UCBT

  • Determine the disease-free survival at 1 after NK UCB + double UCBT

  • Determine the incidence of relapse at 1 after NK UCB + double UCBT

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

  • Myeloablative conditioning regimen: Patients receive fludarabine intravenously (IV) over 1 hour on days -18 to -16 and cyclophosphamide intravenously (IV) on days -18 and -17. Patients undergo total-body irradiation twice daily on days -16 to -13.

  • Haploidentical umbilical cord blood (UCB) natural killer (NK) cell therapy and aldesleukin: Patients undergo haploidentical UCB-enriched NK cell (CD3- depleted) infusion on day -13. Patients then receive aldesleukin subcutaneously on days -13, -11, -9, -7, -5, and -3. Some patients may also receive methylprednisolone IV on days -1 and

  • UCB transplantation (UCBT): Patients undergo a single or double UCBT on day 0. Beginning on day 1, patients receive filgrastim (G-CSF) IV once daily until blood counts recover.

  • Graft-vs-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2 hours 2-3 times daily beginning on day -1 and continuing until day 100, followed by a taper until day 180. Patients also receive mycophenolate mofetil IV or orally 2-3 times daily beginning on day -1 and continuing until day 30 (or 7 days after engraftment) in the absence of acute GVHD.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Transplantation of Umbilical Cord Blood for Myeloid Leukemia Patients Not in CR With Cyclophosphamide/Fludarabine/Total Body Irradiation Myeloablative Preparative Regimen and UCB NK Cells
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treated Patients

All patients receiving treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.

Biological: aldesleukin
10 Million units subcutaneous every other day on days -13 (after Natural killer cell graft), -11, -9, -7, -5, -3) If < 45 kilograms (Kg) - interleukin (IL)-2 at 5 MU/m2
Other Names:
  • IL-2
  • interleukin-2
  • Biological: filgrastim
    All patients will receive filgrastim (same as granulocyte-colony stimulating factor or G-CSF) 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight beginning on day +1 after umbilical cord blood (UCB) infusion. Granulocyte Colony Stimulating Factor (G-CSF) will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10^9/L for three consecutive days and then discontinued. If the ANC decreases to <1.0 x 10^9/L, G-CSF will be reinstituted.
    Other Names:
  • granulocyte colony-stimulating factor (G-CSF)
  • Biological: natural killer cell (NK) therapy
    All CD3 depleted cells will be given (less those required for product monitoring). The minimum size of a starting NK cell unit will be 700 million mononuclear cells before processing. NK cells (CD56+) and NK cell precursors (CD34+/CD7-, CD34+/CD7+, CD34-/CD7+) will be monitored and reported but will not serve as lot release.
    Other Names:
  • NK cells
  • Drug: cyclophosphamide
    Cyclophosphamide to be administered with high volume fluid flush and mesna on days-18 and -17 after fludarabine. Cyclophosphamide 60 mg/kg/day intravenously (IV) x 2 days, total dose 120 mg/m2 (days -18 and -17)
    Other Names:
  • Cytoxan
  • Drug: cyclosporine
    Patients will receive cyclosporine (CSA) therapy beginning on day -1 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:
  • cyclosporin
  • Drug: fludarabine phosphate
    Fludarabine 25 mg/m2/day intravenously (IV) x 3 days, total dose 75 mg/m2 (days -18 to -16)
    Other Names:
  • Fludara
  • Drug: methylprednisolone
    This modification will be enacted based on the engraftment stopping rule on all subsequent patients to stop natural killer (NK) cell reaction. Methylprednisolone bolus 1000 mg intravenously (IV) will be administered day -1 and day 0 (before umbilical cord blood transplant) to suppress natural killer (NK) cell activity before transplant. Starting cyclosporin and mycophenolate mofetil (MMF) will also contribute to suppressing residual NK cell activity.
    Other Names:
  • Medrol
  • Solu-Medrol
  • Depo-Medrol
  • methylprednisolone sodium succinate
  • Drug: mycophenolate mofetil
    All patients will begin mycophenolate mofetil (MMF) on day -1. Patients ≥ 45 kilograms will receive MMF at the dose of 3 grams/day divided into 2 or 3 doses. Pediatric patient (<45 kilograms) will receive MMF at the dose of 15 mg/kg. Use intravenous (IV) route between days -1 and +5, then, if tolerated, may change to by mouth (PO) between days +6 and +30. Stop MMF at day +30 or 7 days after engraftment, whichever day is later, if no acute Graft Versus Host Disease. (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count [ANC] > 0.5 x 10^9 /L).
    Other Names:
  • mycophenolic acid
  • Procedure: Umbilical Cord Blood Transplantation (UCBT)
    The product is infused via intravenous (IV) drip directly into the central line without a needle, pump or filter.
    Other Names:
  • allogeneic transplant
  • Radiation: Total body irradiation (TBI)
    TBI 165 Gray (cGy) will be given twice daily for a total dose of 1320 cGy (days -16 to -13).
    Other Names:
  • radiation
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months [6 Months Post Transplant]

      Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.

    Secondary Outcome Measures

    1. Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months [12 Months Post transplant]

      Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.

    2. Number of Patients Who Were Disease-free and Alive at 24 Months [24 Months Post transplant]

      Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.

    3. Number of Participants (Patients) Who Died Due to Transplant. [6 Months Post Transplant]

      Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.

    4. Number of Participants (Patients) Who Attained Neutrophil Engraftment [Day 42 Post Transplant]

      Defined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days. ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3).

    5. Number of Participants (Patients) Who Attained Platelet Engraftment [1 Year Post Transplant]

      Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days.

    6. Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV [Day 100 Post Transplant]

      Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.

    7. Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV [Day 100 post transplant]

      Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.

    8. Number of Participants (Patients) With Chronic Graft-Versus-Host Disease [Day 100 through 1 Year Post Transplant]

      The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival.

    9. Number of Participants (Patients) Who Died by 12 Months [1 year Post Transplant]

      Number of patients who died after receiving treatment within 12 months post transplant.

    10. Number of Participants (Patients) Who Died by 24 Months [2 years post-transplant]

      Number of patients who died after receiving treatment within 24 months post transplant.

    11. Number of Participants (Patients) Who Experienced Relapse by 12 Months [1 Year Post Transplant]

      Number of patients who experienced recurrence or progression of disease from the time of transplant.

    12. Number of Participants (Patients) Who Experienced Relapse by 24 Months [2 Years Post transplant]

      Number of patients who experienced recurrence or progression of disease from the time of transplant.

    13. Number of Participants (Patients) With Successful Natural Killer Cell Expansion [10-13 Days Post Infusion]

      Defined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population

    14. Chimerism After Double Umbilical Cord Blood Transplant (UCBT) [Day 21, Day 100, 6 Months]

      Calculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of 1 of the following:

    • Acute myeloid leukemia with active leukemia (i.e., not in complete remission [CR]), defined by light microscopy (bone marrow) and having failed ≥ 1 round of standard chemotherapy

    • Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after ≥ 1 course of standard chemotherapy and imatinib mesylate

    • Myelodysplastic syndromes (MDS) or other myeloproliferative disorders more than 10% blasts after ≥ 1 course of standard chemotherapy

    • Unrelated umbilical cord blood (UCB) donor(s) available - Each unit must be 4-6/6 HLA-A, -B, and -DRB1 matched with the recipient (and to each other if 2 units are utilized) (for UCB graft) AND 3/6 HLA-A, -B, and -DRB1 matched with the recipient (for UCB natural killer [NK] cells)

    • Karnofsky performance status (PS) 80-100% (adult patients) or Lansky PS 50-100% (pediatric patients)

    • Creatinine ≤ 2.0 mg/dL (adult patients) OR creatinine clearance > 40 mL/min (pediatric patients)

    • Bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)

    • Corrected Carbon Monoxide Diffusing Capacity (DLCO) > 50% normal OR oxygen saturation

    92% (in pediatric patients who cannot undergo pulmonary function tests)

    • Left ventricular ejection fraction ≥ 45%
    Exclusion Criteria:
    • Pregnant or nursing

    • Positive pregnancy test (Fertile patients must use effective contraception)

    • History of HIV infection

    • Active infection at time of transplantation

    • Active infection with Aspergillus or other mold within the past 120 days

    • Less than 6 months since prior myeloablative transplant (≤ 18 years old)

    • Prior myeloablative allotransplant or autologous transplant (> 18 years old)

    • No prior extensive therapy including > 12 months of any alkylator chemotherapy or > 6 months of alkylator therapy with extensive radiation (e.g., mantle irradiation for Hodgkin's lymphoma)

    • Prior radiation therapy that would make the patient ineligible for total-body irradiation

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Masonic Cancer Center at University of MinnesotaMinneapolisMinnesotaUnited States55455

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    • Principal Investigator: Jeffrey Miller, MD, Masonic Cancer Center, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00354172
    Other Study ID Numbers:
    • UMN-2005LS058
    • MT2005-18
    • 0509M73449
    First Posted:
    Jul 20, 2006
    Last Update Posted:
    Dec 28, 2017
    Last Verified:
    Dec 1, 2017

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitlePatients Treated for Refractory Hematologic Cancers
    Arm/Group DescriptionAll patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Period Title: Overall Study
    STARTED16
    COMPLETED15
    NOT COMPLETED1

    Baseline Characteristics

    Arm/Group TitlePatients Treated for Refractory Hematologic Cancers
    Arm/Group DescriptionAll patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Overall Participants16
    Age (Count of Participants)
    <=18 years
    8
    50%
    Between 18 and 65 years
    8
    50%
    >=65 years
    0
    0%
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    22
    Sex: Female, Male (Count of Participants)
    Female
    8
    50%
    Male
    8
    50%
    Region of Enrollment (participants) [Number]
    United States
    16
    100%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants (Patients) Who Were Disease-free and Alive at 6 Months
    DescriptionNumber of patients who were alive and free of disease (malignancy) at 6 months after transplant.
    Time Frame6 Months Post Transplant

    Outcome Measure Data

    Analysis Population Description
    One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    2
    12.5%
    2. Secondary Outcome
    TitleNumber of Participants (Patients) Who Were Disease-free and Alive at 12 Months
    DescriptionNumber of patients who were alive and free of disease (malignancy) at 12 months after transplant.
    Time Frame12 Months Post transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    1
    6.3%
    3. Secondary Outcome
    TitleNumber of Patients Who Were Disease-free and Alive at 24 Months
    DescriptionNumber of patients who were alive and free of disease (malignancy) at 24 months after transplant.
    Time Frame24 Months Post transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    0
    0%
    4. Secondary Outcome
    TitleNumber of Participants (Patients) Who Died Due to Transplant.
    DescriptionPatients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months.
    Time Frame6 Months Post Transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    4
    25%
    5. Secondary Outcome
    TitleNumber of Participants (Patients) Who Attained Neutrophil Engraftment
    DescriptionDefined as absolute neutrophils (ANC) > 5 x 10^8/Liter for 3 consecutive days. ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3).
    Time FrameDay 42 Post Transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    13
    81.3%
    6. Secondary Outcome
    TitleNumber of Participants (Patients) Who Attained Platelet Engraftment
    DescriptionPlatelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days.
    Time Frame1 Year Post Transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    5
    31.3%
    7. Secondary Outcome
    TitleNumber of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
    DescriptionGraft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.
    Time FrameDay 100 Post Transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    6
    37.5%
    8. Secondary Outcome
    TitleNumber of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
    DescriptionGraft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis.
    Time FrameDay 100 post transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    1
    6.3%
    9. Secondary Outcome
    TitleNumber of Participants (Patients) With Chronic Graft-Versus-Host Disease
    DescriptionThe chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival.
    Time FrameDay 100 through 1 Year Post Transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    1
    6.3%
    10. Secondary Outcome
    TitleNumber of Participants (Patients) Who Died by 12 Months
    DescriptionNumber of patients who died after receiving treatment within 12 months post transplant.
    Time Frame1 year Post Transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    14
    87.5%
    11. Secondary Outcome
    TitleNumber of Participants (Patients) Who Died by 24 Months
    DescriptionNumber of patients who died after receiving treatment within 24 months post transplant.
    Time Frame2 years post-transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    15
    93.8%
    12. Secondary Outcome
    TitleNumber of Participants (Patients) Who Experienced Relapse by 12 Months
    DescriptionNumber of patients who experienced recurrence or progression of disease from the time of transplant.
    Time Frame1 Year Post Transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    10
    62.5%
    13. Secondary Outcome
    TitleNumber of Participants (Patients) Who Experienced Relapse by 24 Months
    DescriptionNumber of patients who experienced recurrence or progression of disease from the time of transplant.
    Time Frame2 Years Post transplant

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    11
    68.8%
    14. Secondary Outcome
    TitleNumber of Participants (Patients) With Successful Natural Killer Cell Expansion
    DescriptionDefined by an absolute circulating donor-derived natural killer cell count of >100 cells/microliter 10-13 days after infusion with <5% donor T and B cells in the mononuclear population
    Time Frame10-13 Days Post Infusion

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Number [Participants]
    3
    18.8%
    15. Secondary Outcome
    TitleChimerism After Double Umbilical Cord Blood Transplant (UCBT)
    DescriptionCalculation of Median (range) of percentage of donor cells engrafted (present) in the recipient (patient).
    Time FrameDay 21, Day 100, 6 Months

    Outcome Measure Data

    Analysis Population Description
    1 Year and 2 Year Post Transplant data was not applicable; no patients reached this timeframe to evaluate.
    Arm/Group TitleEvaluable Patients
    Arm/Group DescriptionAll patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    Measure Participants15
    Day 21
    92
    Day 100
    100
    6 Months
    96.5

    Adverse Events

    Time FrameSerious adverse events were collected if deemed related to treatment from Day 1 through 1 year post transplant. It was expected that most treatment related adverse events would occur during this period.
    Adverse Event Reporting Description Only serious adverse events were captured for this study.
    Arm/Group TitlePatients Treated for Refractory Hematologic Cancers
    Arm/Group DescriptionAll patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
    All Cause Mortality
    Patients Treated for Refractory Hematologic Cancers
    Affected / at Risk (%)# Events
    Total/ (NaN)
    Serious Adverse Events
    Patients Treated for Refractory Hematologic Cancers
    Affected / at Risk (%)# Events
    Total16/16 (100%)
    Blood and lymphatic system disorders
    Death4/16 (25%) 4
    Disease relapse4/16 (25%) 5
    Cardiac disorders
    Cardiac failure1/16 (6.3%) 1
    Hepatobiliary disorders
    Hepatic portal vein flow occluded1/16 (6.3%) 2
    Respiratory, thoracic and mediastinal disorders
    Dyspnea1/16 (6.3%) 2
    Hemorrhage, lung2/16 (12.5%) 2
    Pneumonia3/16 (18.8%) 3
    Other (Not Including Serious) Adverse Events
    Patients Treated for Refractory Hematologic Cancers
    Affected / at Risk (%)# Events
    Total0/0 (NaN)

    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/TitleJeffrey Miller, M.D.
    OrganizationMasonic Cancer Center, University of Minnesota
    Phone612-625-7409
    Emailmille011@umn.edu
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00354172
    Other Study ID Numbers:
    • UMN-2005LS058
    • MT2005-18
    • 0509M73449
    First Posted:
    Jul 20, 2006
    Last Update Posted:
    Dec 28, 2017
    Last Verified:
    Dec 1, 2017