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 : January 4, 2023
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Sponsor:
Medical College of Wisconsin
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
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Study Type | Interventional |
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Study Design | Allocation: N/A; 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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Haplo-marrow Transplantation |
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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 |
Baseline Characteristics
Arm/Group Title | Haplo-marrow Transplantation | |
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Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen. | |
Overall Number of Baseline Participants | 50 | |
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Received transplant.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 50 participants | |
45.4 (18.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | |
Female |
18 36.0%
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Male |
32 64.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | |
Hispanic or Latino |
5 10.0%
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Not Hispanic or Latino |
38 76.0%
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Unknown or Not Reported |
7 14.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 50 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
2 4.0%
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Native Hawaiian or Other Pacific Islander |
1 2.0%
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Black or African American |
6 12.0%
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White |
40 80.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
1 2.0%
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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.
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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.
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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.
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Weight
Median (Full Range) Unit of measure: Kilograms |
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Number Analyzed | 50 participants | |
78
(21 to 184)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Adam Mendizabal |
Organization: | The EMMES Corporation |
Phone: | 301-251-1161 |
EMail: | amendizabal@EMMES.com |
Publications of Results:
Responsible Party: | Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT00849147 |
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: | January 4, 2023 |