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Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)

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ClinicalTrials.gov Identifier: NCT00849147
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : September 7, 2015
Last Update Posted : December 22, 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: Haploidentical Bone Marrow Transplantation
Biological: GVHD prophylaxis
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
Period Title: Overall Study
Started 55
Completed 50
Not Completed 5
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             2
Disease Relapse/Progression             2
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
Received transplant.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
45.4  (18.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
18
  36.0%
Male
32
  64.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
5
  10.0%
Not Hispanic or Latino
38
  76.0%
Unknown or Not Reported
7
  14.0%
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
2
   4.0%
Native Hawaiian or Other Pacific Islander
1
   2.0%
Black or African American
6
  12.0%
White
40
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
   2.0%
Karnofsky Performance-status score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
100% 19
90% 19
80% 9
70% 3
[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 22
Biphenotypic/Undifferentiated Leukemia 3
Hodgkins Lymphoma 7
Large Cell Lymphoma 8
Marginal Zone B-cell Lymphoma 1
Mantle Cell Lymphoma 3
Human leucocyte antigen (HLA) Typing Match Score - GVH direction   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
5/10 28
6/10 12
7/10 9
8/10 1
[1]
Measure Description: HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and –DQB1 loci. A minimum match of 5/10 is required.
HLA Typing Match Score - Host vs Graft (HVG) direction   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
5/10 22
6/10 22
7/10 3
8/10 1
9/10 1
10/10 1
[1]
Measure Description: HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and –DQB1 loci. A minimum match of 5/10 is required.
Weight  
Median (Full Range)
Unit of measure:  Kilograms
Number Analyzed 50 participants
78
(21 to 184)
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 Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
83.7
(70.0 to 91.5)
1 year
62.0
(44.1 to 75.7)
2.Secondary Outcome
Title Neutrophil Recovery
Hide Description Cumulative incidence of neutrophil recovery >500/μL at day +56
Time Frame Measured at Days 28, 56, 90, and 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
96.0
(89.9 to 100.0)
Day 56
96.0
(89.9 to 100.0)
Day 90
100.0
(96.1 to 100.0)
Day 100
100.0
(96.1 to 100.0)
3.Secondary Outcome
Title Primary Graft Failure
Hide Description Primary graft failure is defined as < 5% donor chimerism on all measurements.
Time Frame Measured at Day 67
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
1
4.Secondary Outcome
Title Secondary Graft Failure
Hide Description Secondary graft failure is defined as initial recovery followed by neutropenia with < 5% donor chimerism. If no chimerism assays were performed and absolute neutrophil count is < 500/mm3, then it will be counted as a secondary graft failure.
Time Frame Measured at Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
0
5.Secondary Outcome
Title Platelet Recovery
Hide Description Platelet Recovery to 20K
Time Frame Measured at Days 56, 90, and 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
96.0
(89.7 to 100.0)
Day 90
96.0
(89.7 to 100.0)
Day 100
98.0
(93.1 to 100.0)
6.Secondary Outcome
Title Platelet Recovery
Hide Description Platelet Recovery to 50K
Time Frame Measured at Days 56, 90, and 100
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
76.0
(63.8 to 88.2)
Day 90
76.0
(63.8 to 88.2)
Day 100
76.0
(63.8 to 88.2)
7.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 Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
Chimerism Performed 42
Donor Percentage ≥95% 39
Donor Percentage 5%-95% 2
Donor Percentage <5% 1
8.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 Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
32.0
(18.9 to 45.1)
Grade III-IV Acute GVHD
0.0
(0.0 to 0.0)
9.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 Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
12.9
(2.9 to 22.9)
10.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is defined as the minimum time interval of the times to relapse/recurrence, 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 Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
47.9
(32.0 to 62.2)
11.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 Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow 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
4.0
(0.0 to 9.5)
1 year
7.0
(0.0 to 15.0)
12.Secondary Outcome
Title Infections
Hide Description Number of infections; infections will be reported by anatomic site, date of onset, organism and resolution, if any. Patients will be followed for infection for 1 year post-transplant.
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
36 patients incurred a total number of 108 infection events.
Arm/Group Title Haplo-marrow Transplantation
Hide Arm/Group Description:
Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
1 Infection 14
2 Infections 6
3 Infections 10
4 Infections 2
5 Infections 1
6-10 Infections 2
>10 Infections 1
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 Haplo-marrow Transplantation
Hide Arm/Group Description Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
All-Cause Mortality
Haplo-marrow Transplantation
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Haplo-marrow Transplantation
Affected / at Risk (%) # Events
Total   5/52 (9.62%)    
Cardiac disorders   
Atrial fibrillation * 1  1/52 (1.92%)  1
Cardiac failure congestive * 1  1/52 (1.92%)  1
Infections and infestations   
Pseudomonas infection * 1  1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory distress * 1  1/52 (1.92%)  1
Respiratory failure * 1  1/52 (1.92%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.92%
Haplo-marrow Transplantation
Affected / at Risk (%) # Events
Total   1/52 (1.92%)    
Nervous system disorders   
Headache * 1  1/52 (1.92%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v12.0
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
Layout table for Results Point of Contact information
Name/Title: Adam Mendizabal
Organization: The EMMES Corporation
Phone: 301-251-1161
EMail: amendizabal@EMMES.com
Layout table for additonal information
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00849147     History of Changes
Other Study ID Numbers: BMTCTN0603
U01HL069294 ( U.S. NIH Grant/Contract )
5U24CA076518 ( U.S. NIH Grant/Contract )
First Submitted: February 20, 2009
First Posted: February 23, 2009
Results First Submitted: May 20, 2015
Results First Posted: September 7, 2015
Last Update Posted: December 22, 2017