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Trial record 9 of 48 for:    cord blood | ( Map: Canada )

Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)

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ClinicalTrials.gov Identifier: NCT00412360
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : December 21, 2015
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Marrow Donor Program
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Natural Killer Cell Lymphoblastic Leukemia/Lymphoma
Interventions Biological: Single Umbilical Cord Blood Unit Transplant
Biological: Double Umbilical Cord Blood Unit Transplant
Radiation: Total Body Irradiation
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Cyclosporine A
Drug: Mycophenolate Mofetil
Enrollment 224
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description Single Cord Blood Unit Transplantation: Unrelated donor, single cord blood unit Double Cord Blood Unit Transplantation: Unrelated donor, double cord blood unit
Period Title: Overall Study
Started 113 111
Completed 112 108
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             0             1
Not Transplanted             1             2
Arm/Group Title Single UCB Transplant Double UCB Transplant Total
Hide Arm/Group Description Single Umbilical Cord Blood Unit Transplantation Double Umbilical Cord Blood Unit Transplantation Total of all reporting groups
Overall Number of Baseline Participants 113 111 224
Hide Baseline Analysis Population Description
Analysis based on intent-to-treat.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 113 participants 111 participants 224 participants
10.4  (5.1) 10.4  (5.1) 10.4  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 111 participants 224 participants
Female
55
  48.7%
41
  36.9%
96
  42.9%
Male
58
  51.3%
70
  63.1%
128
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 111 participants 224 participants
Hispanic or Latino
22
  19.5%
20
  18.0%
42
  18.8%
Not Hispanic or Latino
88
  77.9%
88
  79.3%
176
  78.6%
Unknown or Not Reported
3
   2.7%
3
   2.7%
6
   2.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 111 participants 224 participants
American Indian or Alaska Native
1
   0.9%
0
   0.0%
1
   0.4%
Asian
4
   3.5%
5
   4.5%
9
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  11.5%
11
   9.9%
24
  10.7%
White
80
  70.8%
85
  76.6%
165
  73.7%
More than one race
3
   2.7%
3
   2.7%
6
   2.7%
Unknown or Not Reported
12
  10.6%
7
   6.3%
19
   8.5%
Primary Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 111 participants 224 participants
Acute Myelogenous Leukemia (AML)
39
  34.5%
38
  34.2%
77
  34.4%
Acute Lymphoblastic Leukemia (ALL)
61
  54.0%
58
  52.3%
119
  53.1%
Acute Biphenotypic Leukemia
6
   5.3%
2
   1.8%
8
   3.6%
Acute Undifferentiated Leukemia
1
   0.9%
0
   0.0%
1
   0.4%
Myelodysplastic Syndrome (MDS)
5
   4.4%
13
  11.7%
18
   8.0%
Chronic Myelogenous Leukemia (CML)
1
   0.9%
0
   0.0%
1
   0.4%
AML Disease Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 38 participants 77 participants
First Complete Remission (CR)
17
  43.6%
14
  36.8%
31
  40.3%
Second or Later CR
16
  41.0%
19
  50.0%
35
  45.5%
First Relapse
1
   2.6%
3
   7.9%
4
   5.2%
Morphologic CR before Complete-Blood-Count Recover
2
   5.1%
2
   5.3%
4
   5.2%
Secondary or Therapy-related
3
   7.7%
0
   0.0%
3
   3.9%
[1]
Measure Analysis Population Description: Participants with AML
ALL Disease Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
First Complete Remission (CR)
19
  31.1%
19
  32.8%
38
  31.9%
Second CR
29
  47.5%
28
  48.3%
57
  47.9%
Subsequent CR
13
  21.3%
10
  17.2%
23
  19.3%
Morphologic CR before Complete-Blood-Count Recover
0
   0.0%
1
   1.7%
1
   0.8%
[1]
Measure Analysis Population Description: Participants with ALL
Acute Biphenotypic Leukemia Disease Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 8 participants
First Complete Remission (CR)
5
  83.3%
1
  50.0%
6
  75.0%
Second CR
1
  16.7%
1
  50.0%
2
  25.0%
[1]
Measure Analysis Population Description: Participants with Acute Biphenotypic Leukemia
MDS Disease Status   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 13 participants 18 participants
Refractory Anemia
2
  40.0%
0
   0.0%
2
  11.1%
Refractory Cytopenia with Multilineage Dysplasia
2
  40.0%
3
  23.1%
5
  27.8%
Refractory Anemia with Excess Blasts 1 (RAEB1)
0
   0.0%
3
  23.1%
3
  16.7%
Refractory Anemia with Excess Blasts 2 (RAEB2)
0
   0.0%
4
  30.8%
4
  22.2%
Unclassified
1
  20.0%
3
  23.1%
4
  22.2%
[1]
Measure Description: RAEB1: Blast percentage of 5-10%; RAEB2: Blast percentage of 11-20%
[2]
Measure Analysis Population Description: Participants with MDS
Karnofsky Performance Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 111 participants 224 participants
100%
58
  51.3%
57
  51.4%
115
  51.3%
90%
38
  33.6%
43
  38.7%
81
  36.2%
80%
13
  11.5%
9
   8.1%
22
   9.8%
70%
4
   3.5%
2
   1.8%
6
   2.7%
[1]
Measure Description: Assesses patient self-perceived global quality of life and functioning (excellent, very good, good, fair, poor), where 100 equals perfect quality of life.
Recipient CMV Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Positive Number Analyzed 113 participants 111 participants 224 participants
58
  51.3%
66
  59.5%
124
  55.4%
Negative Number Analyzed 113 participants 111 participants 224 participants
51
  45.1%
39
  35.1%
90
  40.2%
Inconclusive Number Analyzed 113 participants 111 participants 224 participants
1
   0.9%
1
   0.9%
2
   0.9%
Unknown Number Analyzed 113 participants 111 participants 224 participants
3
   2.7%
5
   4.5%
8
   3.6%
Weight at Infusion  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 113 participants 111 participants 224 participants
39.6  (20.2) 38.7  (19.2) 39.15  (19.7)
Recipient to First Cord Blood Unit HLA Match   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 108 participants 220 participants
3/6
1
   0.9%
2
   1.9%
3
   1.4%
4/6
44
  39.3%
33
  30.6%
77
  35.0%
5/6
51
  45.5%
59
  54.6%
110
  50.0%
6/6
16
  14.3%
14
  13.0%
30
  13.6%
[1]
Measure Analysis Population Description: Transplanted participants
Recipient to Second Cord Blood Unit HLA Match   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 108 participants 108 participants
3/6
1
   0.9%
1
   0.9%
4/6
43
  39.8%
43
  39.8%
5/6
43
  39.8%
43
  39.8%
6/6
21
  19.4%
21
  19.4%
[1]
Measure Analysis Population Description: Double UCB transplant participants
Recipient to First Cord Blood Unit ABO Match   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 108 participants 220 participants
Major Mismatch
30
  26.8%
25
  23.1%
55
  25.0%
Minor Mismatch
24
  21.4%
35
  32.4%
59
  26.8%
Bidirectional Mismatch
10
   8.9%
8
   7.4%
18
   8.2%
No Mismatch
44
  39.3%
36
  33.3%
80
  36.4%
Unknown
4
   3.6%
4
   3.7%
8
   3.6%
[1]
Measure Description: Blood type matching between recipient and cord blood unit
[2]
Measure Analysis Population Description: Transplanted participants
Recipient to Second Cord Blood Unit ABO Match   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 108 participants 108 participants
Major mismatch
31
  28.7%
31
  28.7%
Minor mismatch
29
  26.9%
29
  26.9%
Bidirectional mismatch
4
   3.7%
4
   3.7%
No mismatch
38
  35.2%
38
  35.2%
Unknown
6
   5.6%
6
   5.6%
[1]
Measure Description: Blood type matching between recipient and cord blood unit
[2]
Measure Analysis Population Description: Double UCB transplant participants
1.Primary Outcome
Title Percentage of Participants With Overall Survival
Hide Description Overall survival is defined as survival of death from any cause.
Time Frame 1 year post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 113 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73
(63 to 80)
65
(56 to 74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments Testing was performed at a significance level of 0.05
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Disease-free Survival
Hide Description Disease-free survival is defined as survival without relapse of the primary disease.
Time Frame 1 year post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 113 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(60 to 77)
64
(54 to 72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments Testing was performed at a significance level of 0.05
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Neutrophil and Platelet Engraftment
Hide Description Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.
Time Frame Days 42 and 100
Hide Outcome Measure Data
Hide Analysis Population Description
Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Neutrophil Engraftment at Day 42
89
(83 to 95)
88
(82 to 94)
Platelet Engraftment at Day 100
76
(68 to 85)
65
(56 to 74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
4.Secondary Outcome
Title Time to Neutrophil and Platelet Engraftment
Hide Description Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.
Time Frame 2 years post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Median (Full Range)
Unit of Measure: days
Neutrophil Engraftment
21
(11 to 62)
23
(11 to 133)
Platelet Engraftment
58
(28 to 295)
84
(22 to 716)
5.Secondary Outcome
Title Percentage of Participants With Acute Graft-versus-host Disease (GVHD)
Hide Description

Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:

Skin stage:

0: No rash

  1. Rash <25% of body surface area
  2. Rash on 25-50% of body surface area
  3. Rash on > 50% of body surface area
  4. Generalized erythroderma with bullous formation

Liver stage (based on bilirubin level)*:

0: <2 mg/dL

  1. 2-3 mg/dL
  2. 3.01-6 mg/dL
  3. 6.01-15.0 mg/dL
  4. >15 mg/dL

GI stage*:

0: No diarrhea or diarrhea <500 mL/day

  1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD
  2. Diarrhea 1000-1499 mL/day
  3. Diarrhea >1500 mL/day
  4. Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.

GVHD grade:

0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4

Time Frame Day 100 post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Acute GVHD Grade II-IV
57
(48 to 67)
56
(47 to 65)
Acute GVHD Grade III-IV
13
(7 to 20)
23
(15 to 31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Chronic GVHD
Hide Description Incidences of chronic GVHD will be graded per Shulman et al. 1980. This reference categorizes chronic GVHD as either limited or extensive. For this outcome, participants developing either type are considered to have a chronic GVHD event.
Time Frame 1 year post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Chronic GVHD
30
(22 to 39)
32
(23 to 40)
Extensive Chronic GVHD
9
(4 to 14)
15
(8 to 22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
7.Secondary Outcome
Title Number of Infections Per Participant
Hide Description [Not Specified]
Time Frame 2 years post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Measure Type: Count of Participants
Unit of Measure: Participants
0
10
   8.9%
9
   8.3%
1
15
  13.4%
13
  12.0%
2
12
  10.7%
15
  13.9%
3
19
  17.0%
10
   9.3%
4
17
  15.2%
15
  13.9%
5
7
   6.3%
12
  11.1%
6-10
19
  17.0%
24
  22.2%
More than 10
13
  11.6%
10
   9.3%
8.Secondary Outcome
Title Percentage of Participants With Relapse
Hide Description Relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features. Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation.
Time Frame 1 year post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12
(6 to 18)
14
(7 to 21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Treatment-related Mortality
Hide Description Treatment related mortality is defined as death without relapse of the primary disease.
Time Frame 1 year post-randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description:
Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19
(11 to 26)
22
(14 to 30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single UCB Transplant, Double UCB Transplant
Comments The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments Testing was performed at a significance level of 0.05
Method Gray's test
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants With Engraftment Syndrome
Hide Description [Not Specified]
Time Frame Day 100 post-transplant
Hide Outcome Measure Data
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Transplanted participants
Arm/Group Title Single UCB Transplant Double UCB Transplant
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Single Umbilical Cord Blood Unit Transplantation
Double Umbilical Cord Blood Unit Transplantation
Overall Number of Participants Analyzed 112 108
Measure Type: Count of Participants
Unit of Measure: Participants
11
   9.8%
7
   6.5%
Time Frame 2 years post-transplant
Adverse Event Reporting Description Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.
 
Arm/Group Title Single UCB Transplant Double UCB Transplant
Hide Arm/Group Description Single Umbilical Cord Blood Unit Transplantation Double Umbilical Cord Blood Unit Transplantation
All-Cause Mortality
Single UCB Transplant Double UCB Transplant
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single UCB Transplant Double UCB Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/112 (4.46%)      14/108 (12.96%)    
Blood and lymphatic system disorders     
Hemolytic anemia * 1  0/112 (0.00%)  0 2/108 (1.85%)  2
Cardiac disorders     
Congestive heart failure * 1  1/112 (0.89%)  1 1/108 (0.93%)  1
Gastrointestinal disorders     
Abdominal pain * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
Infections and infestations     
Pneumonia * 1 [1]  0/112 (0.00%)  0 1/108 (0.93%)  1
Septic shock * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
Metabolism and nutrition disorders     
Hyperglycemia * 1  2/112 (1.79%)  2 0/108 (0.00%)  0
Nervous system disorders     
Acute intracranial Hemorrage * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
Seizure/aspiration Pneumonia * 1  1/112 (0.89%)  1 0/108 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  0/112 (0.00%)  0 2/108 (1.85%)  2
Pulmonary Hemorrage * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
Aspiration * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
Aspiration Pneumonia * 1  1/112 (0.89%)  1 0/108 (0.00%)  0
Vascular disorders     
Hypotension * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
Hypertension * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
Hematoma * 1  0/112 (0.00%)  0 1/108 (0.93%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[1]
Respiratory failure from Pneumonia
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Frequency Threshold for Reporting Other Adverse Events 0%
Single UCB Transplant Double UCB Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/108 (0.00%)    
Certain Agreements
Principal Investigators are NOT 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
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Name/Title: Adam Mendizabal
Organization: The EMMES Corporation
Phone: 301-251-1161
EMail: amendizabal@EMMES.com
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Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00412360     History of Changes
Obsolete Identifiers: NCT00429598
Other Study ID Numbers: BMTCTN0501
2U01HL069294 ( U.S. NIH Grant/Contract )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2006
First Posted: December 18, 2006
Results First Submitted: August 28, 2015
Results First Posted: December 21, 2015
Last Update Posted: May 3, 2018