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Chemotherapy, Total-Body Irradiation, Donor Natural Killer Cell Infusion, Aldesleukin, and UCB Transplant in Treating Patients With Relapsed or Refractory AML

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ClinicalTrials.gov Identifier: NCT00871689
Recruitment Status : Terminated (Due to graft failure.)
First Posted : March 30, 2009
Results First Posted : July 16, 2012
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
Condition Leukemia
Interventions Biological: aldesleukin
Drug: cyclophosphamide
Drug: fludarabine phosphate
Procedure: umbilical cord blood transplantation
Radiation: total-body irradiation
Enrollment 2
Recruitment Details Study entry was open to patients aged 0 to 45 years regardless of gender or ethnic background at the University of Minnesota, Masonic Cancer Center.
Pre-assignment Details  
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
2
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants
10.5  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Number of Patients With Neutrophil Engraftment
Hide Description Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
1
2.Primary Outcome
Title Number of Patients With Grade III-IV Acute Graft-Versus-Host (GVHD) Disease
Hide Description

Number of patients with Grade III-IV GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.

Acute GVHD usually happens within the first 3 months after transplant.

Time Frame Day 100 Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Incidence of Primary Graft Failure
Hide Description Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia) on day 42.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
1
4.Secondary Outcome
Title Number of Patients With Acute Graft-Versus-Host (GVHD) Disease
Hide Description

Number of patients with any grade of GVHD. Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.

Acute GVHD usually happens within the first 3 months after transplant.

Time Frame Day 100 Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
1
5.Secondary Outcome
Title Number of Patients With Transplant-Related Death (TRD)
Hide Description Number of patients whose death is related to study treatment received. TRD is defined as the number of patients that die without prior relapse.
Time Frame 1 Year Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
1
6.Secondary Outcome
Title Number of Patients With Complete Remission of Disease
Hide Description Disease response will be measured by rate of leukemic clearance (clearance of blasts in blood at timepoint 0) and complete remission (less than 5% blasts and recovery of hematopoiesis).
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Participants
1
7.Secondary Outcome
Title Median Overall Survival
Hide Description Average number of days the patients were alive after receiving UCB transplantation.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: Days
98.5
(98 to 99)
8.Secondary Outcome
Title Number of Patients With Successful Natural Killer Expansion
Hide Description Successful in vivo donor NK cell expansion will be defined as an absolute circulating donor-derived NK cell count of >100 cells/μl.
Time Frame Day 72 Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description:
Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
1
Time Frame Patients were followed from Day 1 up to death ( within 6 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Receiving Double Umbilical Cord Blood Transplant
Hide Arm/Group Description Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
All-Cause Mortality
Patients Receiving Double Umbilical Cord Blood Transplant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Receiving Double Umbilical Cord Blood Transplant
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Leukoencephalopathy  1  1/2 (50.00%)  2
General disorders   
Death  1  2/2 (100.00%)  2
Progressive Disease  1  1/2 (50.00%)  1
Nervous system disorders   
CNS Demyelinating Disease  1  1/2 (50.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Receiving Double Umbilical Cord Blood Transplant
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Cardiac disorders   
Hypertension  1  1/2 (50.00%)  3
Hypotension  1  1/2 (50.00%)  1
Endocrine disorders   
Edema  1  2/2 (100.00%)  4
Gastrointestinal disorders   
Nausea  1  1/2 (50.00%)  2
Vomiting  1  1/2 (50.00%)  2
General disorders   
Fever  1  2/2 (100.00%)  7
Fatigue  1  2/2 (100.00%)  6
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/2 (50.00%)  3
Nervous system disorders   
Chills  1  2/2 (100.00%)  6
Sweats  1  1/2 (50.00%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/2 (100.00%)  4
Hypoxia  1  1/2 (50.00%)  1
Pneumonitis  1  1/2 (50.00%)  2
Cough  1  1/2 (50.00%)  1
Lung disorder  1  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Injection site reaction  1  2/2 (100.00%)  3
Rash  1  2/2 (100.00%)  3
Skin disorder  1  1/2 (50.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Quantitative, phenotypic and functional assessment of the in vivo expanded UCB-derived NK cells on Day 72 were not performed. Patients were not well enough to provide research samples.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael Verneris, M.D.
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-2961
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00871689     History of Changes
Other Study ID Numbers: 2008LS110
MT2008-36 ( Other Identifier: Blood and Marrow Transplantation Program )
0810M51781 ( Other Identifier: IRB, University of Minnesota )
First Submitted: March 27, 2009
First Posted: March 30, 2009
Results First Submitted: June 11, 2012
Results First Posted: July 16, 2012
Last Update Posted: December 28, 2017