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

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ClinicalTrials.gov Identifier: NCT00354172
Recruitment Status : Terminated (Competing study was started.)
First Posted : July 20, 2006
Results First Posted : December 31, 2009
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Myelodysplastic Syndromes
Interventions Biological: aldesleukin
Biological: filgrastim
Biological: natural killer cell (NK) therapy
Drug: cyclophosphamide
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: methylprednisolone
Drug: mycophenolate mofetil
Procedure: Umbilical Cord Blood Transplantation (UCBT)
Radiation: Total body irradiation (TBI)
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Treated for Refractory Hematologic Cancers
Hide Arm/Group Description All 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
Started 16
Completed 15 [1]
Not Completed 1
Reason Not Completed
Did not receive transplant             1
[1]
1 patient did not reach umbilical cord blood transplant
Arm/Group Title Patients Treated for Refractory Hematologic Cancers
Hide Arm/Group Description All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
8
  50.0%
Between 18 and 65 years
8
  50.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 16 participants
22
(3 to 43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months
Hide Description Number of patients who were alive and free of disease (malignancy) at 6 months after transplant.
Time Frame 6 Months Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group.
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
2
2.Secondary Outcome
Title Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months
Hide Description Number of patients who were alive and free of disease (malignancy) at 12 months after transplant.
Time Frame 12 Months Post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
1
3.Secondary Outcome
Title Number of Patients Who Were Disease-free and Alive at 24 Months
Hide Description Number of patients who were alive and free of disease (malignancy) at 24 months after transplant.
Time Frame 24 Months Post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
0
4.Secondary Outcome
Title Number of Participants (Patients) Who Died Due to Transplant.
Hide Description 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.
Time Frame 6 Months Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
4
5.Secondary Outcome
Title Number of Participants (Patients) Who Attained Neutrophil Engraftment
Hide Description

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).

Time Frame Day 42 Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
13
6.Secondary Outcome
Title Number of Participants (Patients) Who Attained Platelet Engraftment
Hide Description Platelet engraftment is defined as platelet counts > 50 x 10^9/Liter for 3 consecutive days.
Time Frame 1 Year Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
5
7.Secondary Outcome
Title Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV
Hide Description 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.
Time Frame Day 100 Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
6
8.Secondary Outcome
Title Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV
Hide Description 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.
Time Frame Day 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
1
9.Secondary Outcome
Title Number of Participants (Patients) With Chronic Graft-Versus-Host Disease
Hide Description 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.
Time Frame Day 100 through 1 Year Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
1
10.Secondary Outcome
Title Number of Participants (Patients) Who Died by 12 Months
Hide Description Number of patients who died after receiving treatment within 12 months post transplant.
Time Frame 1 year Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
14
11.Secondary Outcome
Title Number of Participants (Patients) Who Died by 24 Months
Hide Description Number of patients who died after receiving treatment within 24 months post transplant.
Time Frame 2 years post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
15
12.Secondary Outcome
Title Number of Participants (Patients) Who Experienced Relapse by 12 Months
Hide Description Number of patients who experienced recurrence or progression of disease from the time of transplant.
Time Frame 1 Year Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
10
13.Secondary Outcome
Title Number of Participants (Patients) Who Experienced Relapse by 24 Months
Hide Description Number of patients who experienced recurrence or progression of disease from the time of transplant.
Time Frame 2 Years Post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
11
14.Secondary Outcome
Title Number of Participants (Patients) With Successful Natural Killer Cell Expansion
Hide Description 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
Time Frame 10-13 Days Post Infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Participants
3
15.Secondary Outcome
Title Chimerism After Double Umbilical Cord Blood Transplant (UCBT)
Time Frame Day 21, Day 100, 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
1 Year and 2 Year Post Transplant data was not applicable; no patients reached this timeframe to evaluate.
Arm/Group Title Evaluable Patients
Hide Arm/Group Description:
All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
Overall Number of Participants Analyzed 15
Median (Full Range)
Unit of Measure: Percentage of Engrafted Cells
Day 21
92
(14 to 100)
Day 100
100
(47 to 100)
6 Months
96.5
(93 to 100)
Time Frame Serious 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 Title Patients Treated for Refractory Hematologic Cancers
Hide Arm/Group Description All 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Treated for Refractory Hematologic Cancers
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
Death  1 [1]  4/16 (25.00%)  4
Disease relapse  1  4/16 (25.00%)  5
Cardiac disorders   
Cardiac failure  1  1/16 (6.25%)  1
Hepatobiliary disorders   
Hepatic portal vein flow occluded  1  1/16 (6.25%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/16 (6.25%)  2
Hemorrhage, lung  1  2/16 (12.50%)  2
Pneumonia  1  3/16 (18.75%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Death was due to transplant procedure.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Treated for Refractory Hematologic Cancers
Affected / at Risk (%) # Events
Total   0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jeffrey Miller, M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-625-7409
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00354172     History of Changes
Other Study ID Numbers: UMN-2005LS058
MT2005-18 ( Other Identifier: Blood and Bone Marrow Transplantation Program )
0509M73449 ( Other Identifier: IRB, University of Minnesota )
First Submitted: July 19, 2006
First Posted: July 20, 2006
Results First Submitted: November 30, 2009
Results First Posted: December 31, 2009
Last Update Posted: December 28, 2017