Trial Outcomes & Findings for Haploid Allogeneic Transplant Using the CliniMACS System (NCT NCT00185679)
NCT ID: NCT00185679
Last Updated: 2015-03-09
Results Overview
Number of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC \> 0.5x10e9/L
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
30 days post-transplant
Results posted on
2015-03-09
Participant Flow
Participant milestones
| Measure |
Haploidentical Allogeneic Transplant Using CliniMACS System
The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
1. Computer-controlled instrument;
2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
4. Wash buffer
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Haploid Allogeneic Transplant Using the CliniMACS System
Baseline characteristics by cohort
| Measure |
Haploidentical Allogeneic Transplant Using CliniMACS System
n=13 Participants
The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
The CliniMACS System is a cell selection device consisting of the following components:
1. Computer-controlled instrument;
2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
4. Wash buffer
|
|---|---|
|
Age, Continuous
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27 years
n=93 Participants
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Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
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Sex: Female, Male
Male
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7 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 30 days post-transplantNumber of subjects recovering neutrophils, assessed as 1st of 3 consecutive days on which ANC \> 0.5x10e9/L
Outcome measures
| Measure |
Haploidentical Allogeneic Transplant Using CliniMACS System
n=13 Participants
The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
1. Computer-controlled instrument;
2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
4. Wash buffer
|
|---|---|
|
Neutrophil Engraftment
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12 participants
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SECONDARY outcome
Timeframe: within 100 days post-transplantNumber of subjects with acute GvHD (grade II-IV) within 100 days post-transplant, per the Consensus Conference on Acute GvHD Grading (Przepiorka D, et al. Bone Marrow Transplantation. 1995. 15:825-828).
Outcome measures
| Measure |
Haploidentical Allogeneic Transplant Using CliniMACS System
n=13 Participants
The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
1. Computer-controlled instrument;
2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
4. Wash buffer
|
|---|---|
|
Acute GvHD (Grade II-IV)
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1 participants
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SECONDARY outcome
Timeframe: 40 daysNumber of subjects recovering platelets to \> 20x10e9/L, assessed on the 7th day unsupported by platelet transfusions
Outcome measures
| Measure |
Haploidentical Allogeneic Transplant Using CliniMACS System
n=13 Participants
The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
1. Computer-controlled instrument;
2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
4. Wash buffer
|
|---|---|
|
Platelet Recovery
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12 participants
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Adverse Events
Haploidentical Allogeneic Transplant Using CliniMACS System
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Haploidentical Allogeneic Transplant Using CliniMACS System
n=13 participants at risk
The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.
CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:
1. Computer-controlled instrument;
2. Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)
3. Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)
4. Wash buffer
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment-related secondary malignancy
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15.4%
2/13 • Number of events 2 • SAEs reported through Day 100 post-transplant.
Non-serious adverse events not reported
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|
Infections and infestations
Infections and infestations - Other, demyelinating ecephalitis
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7.7%
1/13 • Number of events 1 • SAEs reported through Day 100 post-transplant.
Non-serious adverse events not reported
|
|
Endocrine disorders
Adrenal insufficiency
|
7.7%
1/13 • Number of events 1 • SAEs reported through Day 100 post-transplant.
Non-serious adverse events not reported
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, pulmonary fungal infection
|
7.7%
1/13 • Number of events 1 • SAEs reported through Day 100 post-transplant.
Non-serious adverse events not reported
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Gastrointestinal disorders
Nausea
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7.7%
1/13 • Number of events 1 • SAEs reported through Day 100 post-transplant.
Non-serious adverse events not reported
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General disorders
Death NOS - Other, graft failure
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7.7%
1/13 • Number of events 1 • SAEs reported through Day 100 post-transplant.
Non-serious adverse events not reported
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place