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Trial record 12 of 372 for:    cord blood stem cells

Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00864227
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : August 28, 2015
Last Update Posted : October 27, 2017
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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Burkitt Lymphoma
Lymphoma, B-Cell
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Interventions Biological: Hematopoietic Umbilical Cord Blood Stem Cell Transplantation
Biological: GVHD prophylaxis
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title dUCB Transplant
Hide Arm/Group Description Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Period Title: Overall Study
Started 54
Completed 50
Not Completed 4
Reason Not Completed
Withdrawal by Subject             1
Disease Relapse/Progression             3
Arm/Group Title dUCB Transplant
Hide Arm/Group Description Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
53.4  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
24
  48.0%
Male
26
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
2
   4.0%
Not Hispanic or Latino
46
  92.0%
Unknown or Not Reported
2
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   8.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   2.0%
White
45
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Karnofsky Performance-status Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
100% 10
90% 30
80% 7
70% 2
60% 1
[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.
Primary Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
Acute Lymphoblastic Leukemia 6
Acute Myelogeneous Leukemia 29
Biphenotypic/Undifferentiated Leukemia 1
Burkitt's Lymphoma 1
Hodgkins Lymphoma 5
Large Cell Lymphoma 3
Marginal Zone B-cell Lymphoma 1
Follicular Non-Hodgkins Lymphoma 4
HLA Typing Match Score - 1st Cord   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
4/6 24
5/6 21
6/6 5
[1]
Measure Description: Units must be HLA-matched at 4 of 6 HLA-A and B (intermediate resolution molecular typing) and DRB1 (high resolution molecular typing) with each other and 4 of 6 with the recipient.
HLA Typing Match Score - 2nd Cord   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
4/6 30
5/6 17
6/6 3
[1]
Measure Description: Units must be HLA-matched at 4 of 6 HLA-A and B (intermediate resolution molecular typing) and DRB1 (high resolution molecular typing) with each other and 4 of 6 with the recipient.
HLA Typing Match Score - 1st Cord to 2nd Cord   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
4/6 35
5/6 11
6/6 4
[1]
Measure Description: Units must be HLA-matched at 4 of 6 HLA-A and B (intermediate resolution molecular typing) and DRB1 (high resolution molecular typing) with each other and 4 of 6 with the recipient.
1.Primary Outcome
Title Overall Survival at 180 Days From the Time of Transplant
Hide Description [Not Specified]
Time Frame Measured at Month 6 and Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6 months
73.5
(58.8 to 83.7)
1 year
54.0
(38.3 to 67.3)
2.Secondary Outcome
Title Neutrophil Recovery
Hide Description Neutrophil recovery is defined as achieving an absolute neutrophil count ≥ 500/mm3 for three consecutive measurements on different days.
Time Frame Measured at Days 28, 56, 90, and 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 28
86.0
(76.0 to 96.0)
Day 56
94.0
(86.6 to 100.0)
Day 90
94.0
(86.6 to 100.0)
Day 100
94.0
(86.6 to 100.0)
3.Secondary Outcome
Title Primary Graft Failure
Hide Description Primary graft failure is defined as < 5% donor chimerism on all measurements prior to and day-100.
Time Frame Measured at Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
5
4.Secondary Outcome
Title Secondary Graft Failure
Hide Description Secondary graft failure is defined initial recovery followed by neutropenia with < 5% donor chimerism.
Time Frame Measured at Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
1
5.Secondary Outcome
Title Platelet Recovery to 20K
Hide Description Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >20,000/mm3 with no platelet transfusions in the preceding seven days.
Time Frame Measured at Days 56, 90, and 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 56
70.0
(57.1 to 82.9)
Day 90
82.0
(71.0 to 93.0)
Day 100
82.0
(71.0 to 93.0)
6.Secondary Outcome
Title Donor Cell Engraftment
Hide Description Marrow or Blood Sample. Donor cell engraftment is defined as donor chimerism ≥ 5% on Day ≥ 56 after transplantation. Chimerism should be evaluated on Days ~28, ~56, ~180, and ~365 after transplantation. Chimerism may be evaluated in whole blood or mononuclear fraction.
Time Frame Measured at Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Chimerism Performed 36
Donor Percentage >=95% 30
Donor Percentage 5%-95% 6
Donor Percentage <5% 0
7.Secondary Outcome
Title Acute Graft-versus-host Disease (GVHD)
Hide Description [Not Specified]
Time Frame Measured at Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Grade II-IV Acute GVHD
40.0
(26.3 to 53.7)
Grade III-IV Acute GVHD
21.4
(5.9 to 36.9)
8.Secondary Outcome
Title Chronic GVHD
Hide Description [Not Specified]
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.3
(11.8 to 38.8)
9.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is defined as the minimum time interval to relapse/ recurrence/progression, to death or to last follow-up.
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45.7
(30.7 to 59.6)
10.Secondary Outcome
Title Treatment-related Mortality (TRM)
Hide Description [Not Specified]
Time Frame Measured at 6 months and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6 months
16.3
(5.9 to 26.7)
1 year
23.8
(11.3 to 36.3)
11.Secondary Outcome
Title Incidence of Infections
Hide Description Number of participants that experienced at least one infection.
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: Infections
1 Infection 11
2 Infections 11
3 Infections 3
4 Infections 4
5 Infections 3
6-10 Infections 8
>10 Infections 1
12.Secondary Outcome
Title Platelet Recovery to 50K
Hide Description Platelet recovery is defined as the first day of a minimum of three consecutive measurements on different days such that the patient has achieved a platelet count >50,000/mm3 with no platelet transfusions in the preceding seven days.
Time Frame Measured at Days 56, 90, and 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title dUCB Transplant
Hide Arm/Group Description:
Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 56
46.0
(31.9 to 60.1)
Day 90
58.5
(44.4 to 72.6)
Day 100
58.5
(44.4 to 72.6)
Time Frame 1-year post-transplant
Adverse Event Reporting Description Serious adverse events 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.
 
Arm/Group Title dUCB Transplant
Hide Arm/Group Description Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
All-Cause Mortality
dUCB Transplant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
dUCB Transplant
Affected / at Risk (%) # Events
Total   9/50 (18.00%)    
Cardiac disorders   
Cardiac failure congestive * 1  1/50 (2.00%)  1
Left ventricular dysfunction * 1  2/50 (4.00%)  2
General disorders   
Chest pain * 1  1/50 (2.00%)  1
Hepatobiliary disorders   
Gallbladder obstruction * 1  1/50 (2.00%)  1
Infections and infestations   
Infection * 1  1/50 (2.00%)  1
Metabolism and nutrition disorders   
Hypercalcaemia * 1  1/50 (2.00%)  1
Hypokalaemia * 1  1/50 (2.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer * 1  1/50 (2.00%)  1
Nervous system disorders   
Toxic encephalopathy * 1  1/50 (2.00%)  1
Psychiatric disorders   
Delirium * 1  1/50 (2.00%)  1
Renal and urinary disorders   
Renal failure * 1  2/50 (4.00%)  2
Surgical and medical procedures   
Mechanical ventilation * 1  1/50 (2.00%)  1
Vascular disorders   
Hypertension * 1  1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
dUCB Transplant
Affected / at Risk (%) # Events
Total   1/50 (2.00%)    
Nervous system disorders   
Headache * 1  1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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
Name/Title: Adam Mendizabal
Organization: The EMMES Corporation
Phone: 301-251-1161
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00864227     History of Changes
Other Study ID Numbers: BMTCTN0604
U01HL069294 ( U.S. NIH Grant/Contract )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: March 17, 2009
First Posted: March 18, 2009
Results First Submitted: May 20, 2015
Results First Posted: August 28, 2015
Last Update Posted: October 27, 2017