Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia
Study Details
Study Description
Brief Summary
RATIONALE: A bone marrow or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving combination chemotherapy before a donor stem cell transplant may make the transplant more likely to work. This may be an effective treatment for patients with high risk Fanconi's anemia.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating high risk patients who are undergoing a donor stem cell transplant for Fanconi's anemia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- Determine whether the incidence of neutrophil engraftment is acceptable in high-risk patients with Fanconi's anemia treated with busulfan, cyclophosphamide, fludarabine, and antithymocyte globulin followed by allogeneic hematopoietic stem cell transplantation.
Secondary
-
Determine the tolerability of mycophenolate mofetil in these patients.
-
Determine the incidence of acute and chronic graft-vs-host disease in patients treated with this regimen.
-
Determine the incidence of major infections in patients with a history of major infections treated with this regimen.
-
Determine the incidence of relapse in patients with refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, or acute myeloid leukemia treated with this regimen
-
Determine the probability of 1-year survival of patients treated with this regimen.
OUTLINE: Patients are stratified according to donor/recipient HLA type (identical vs other).
-
Cytoreductive combination chemotherapy: Patients receive busulfan intravenously (IV) over 2 hours twice daily on days -7 and -6 and cyclophosphamide IV over 2 hours and fludarabine IV over 30 minutes once daily on days -5 to -2.
-
Graft failure prophylaxis: Patients receive methylprednisolone IV twice daily on days -5 to 30 and anti-thymocyte globulin IV over 4-6 hours twice daily on days -5 to -1.
-
Graft-vs-host disease prophylaxis: Patients receive cyclosporine IV over 2 hours twice daily on days -3 to 100 (if patient has a matched sibling donor) or days -3 to 180 (if patient has another donor type). Patients also receive mycophenolate mofetil orally or IV twice daily on days -3 to 45.
-
Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT (using bone marrow or umbilical cord blood) on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover.
After completion of study treatment, patients are followed periodically for 3 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Marrow Isolex Bone marrow processed using Isolex300i |
Biological: anti-thymocyte globulin
Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.
Other Names:
Biological: filgrastim
given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10^9/L)
Other Names:
Drug: busulfan
Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if <4 years old)
Other Names:
Drug: cyclophosphamide
10 mg/kg intravenously (IV) on Days -5 through -2.
Other Names:
Drug: fludarabine phosphate
35 mg/m^2 intravenously (IV) on Days -5 through -2.
Other Names:
Drug: methylprednisolone
1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.
Other Names:
Biological: Hematopoietic stem cell transplantation
Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.
Other Names:
|
Experimental: USB arm No processing |
Biological: anti-thymocyte globulin
Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.
Other Names:
Biological: filgrastim
given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10^9/L)
Other Names:
Drug: busulfan
Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if <4 years old)
Other Names:
Drug: cyclophosphamide
10 mg/kg intravenously (IV) on Days -5 through -2.
Other Names:
Drug: fludarabine phosphate
35 mg/m^2 intravenously (IV) on Days -5 through -2.
Other Names:
Drug: methylprednisolone
1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.
Other Names:
Biological: Hematopoietic stem cell transplantation
Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.
Other Names:
|
Experimental: Marrow Clinimacs Bone marrow processed using CliniMACS system |
Biological: anti-thymocyte globulin
Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.
Other Names:
Biological: filgrastim
given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10^9/L)
Other Names:
Drug: busulfan
Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if <4 years old)
Other Names:
Drug: cyclophosphamide
10 mg/kg intravenously (IV) on Days -5 through -2.
Other Names:
Drug: fludarabine phosphate
35 mg/m^2 intravenously (IV) on Days -5 through -2.
Other Names:
Drug: methylprednisolone
1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.
Other Names:
Biological: Hematopoietic stem cell transplantation
Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.
Other Names:
|
Experimental: Sibling without CliniMacs Sibling donor without the use of CliniMACS system |
Biological: anti-thymocyte globulin
Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.
Other Names:
Biological: filgrastim
given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10^9/L)
Other Names:
Drug: busulfan
Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if <4 years old)
Other Names:
Drug: cyclophosphamide
10 mg/kg intravenously (IV) on Days -5 through -2.
Other Names:
Drug: fludarabine phosphate
35 mg/m^2 intravenously (IV) on Days -5 through -2.
Other Names:
Drug: methylprednisolone
1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.
Other Names:
Biological: Hematopoietic stem cell transplantation
Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Experiencing Graft Failure [Day 30]
Graft failure is defined as absolute neutrophil count( ANC ) <5 x 10^8/L by day 30.
Secondary Outcome Measures
- Number of Participants Experiencing Chronic Graft-Versus-Host Disease [Day 42]
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host.
- Number of Participants Experiencing Chronic Graft-Versus-Host Disease [1 year]
Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host.
- Number of Participants Experiencing Acute Graft-Versus-Host Disease [1 year]
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
- Number of Participants Experiencing Acute Graft-Versus-Host Disease [Day 42]
Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
- Number of Participants Experiencing Relapse [1 Year]
Patients with leukemia will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate.
- Number of Participants Experiencing Overall Survival [1 Year]
Overall Survival - Number of patients alive at 1 year post transplant
- Number of Participants Experiencing Major Infections [Day 1 through 1 year post-transplant]
Number of participants experiencing Major Infections by the end of treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must be <45 years of age with a diagnosis of Fanconi anemia with:
-
Biallelic BRCA2 mutations, or
-
Aplastic anemia, or advanced myelodysplastic syndrome (MDS) (MDS with ≥5% blasts), or acute leukemia who are ineligible for total body irradiation. Aplastic anemia is defined as having at least one of the following (with or without cytogenetic abnormalities): platelet count <20 * 109, - absolute neutrophil count (ANC) <5 * 108/L, - Hgb <8 g/dL
-
Patients must have an HLA-A, B, DRB1 identical or 1 antigen mismatched related or unrelated BM donor or have an HLA-A, B, DRB1 identical, 1 antigen or 2 antigen mismatched related or unrelated umbilical cord blood (UCB) donor. Patients and donors will be typed for HLA-A and B using serological level typing and for DRB1 using high resolution molecular typing.
-
Adequate major organ function including:
-
Cardiac: ejection fraction >45%
-
Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites, no cirrhosis)
-
Karnofsky performance status >70% or Lansky >50%
-
Women of child bearing potential must be using adequate birth control and have a negative pregnancy test.
Exclusion Criteria:
-
Active CNS leukemia at time of HSCT.
-
Active uncontrolled infection within one week of hematopoietic stem cell transplant (HSCT).
-
Pregnant or lactating female.
Donor Inclusion Criteria:
-
Donor must be in good health based on review of systems and results of physical examination.
-
Donor must have a normal hemoglobin, white count, platelet count and partial thromboplastin time (PTT), and a negative diepoxybutane (DEB) test.
-
HIV-NAT negative, HTLV-1, HTLV-2 negative, Hepatitis B and C negative.
-
Female donors of childbearing potential must have a negative pregnancy test.
-
Unrelated donors must agree to peripheral blood stem cell (PBSC) donation
Donor Exclusion Criteria:
- Donor is a lactating female.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- Masonic Cancer Center, University of Minnesota
Investigators
- Principal Investigator: Margaret MacMillan, MD, Masonic Cancer Center, University of Minnesota
Study Documents (Full-Text)
More Information
Publications
None provided.- 2002LS014
- MT2002-02
- 0202M18741
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Period Title: Overall Study | ||||
STARTED | 3 | 8 | 2 | 1 |
COMPLETED | 3 | 8 | 2 | 1 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS | Total |
---|---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system | Total of all reporting groups |
Overall Participants | 3 | 8 | 2 | 1 | 14 |
Age (Count of Participants) | |||||
<=18 years |
1
33.3%
|
8
100%
|
2
100%
|
1
100%
|
12
85.7%
|
Between 18 and 65 years |
2
66.7%
|
0
0%
|
0
0%
|
0
0%
|
2
14.3%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||||
Female |
1
33.3%
|
3
37.5%
|
1
50%
|
0
0%
|
5
35.7%
|
Male |
2
66.7%
|
5
62.5%
|
1
50%
|
1
100%
|
9
64.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
3
100%
|
8
100%
|
2
100%
|
1
100%
|
14
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
1
7.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
3
37.5%
|
0
0%
|
0
0%
|
3
21.4%
|
White |
3
100%
|
2
25%
|
2
100%
|
1
100%
|
8
57.1%
|
More than one race |
0
0%
|
2
25%
|
0
0%
|
0
0%
|
2
14.3%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||||
United States |
3
100%
|
8
100%
|
2
100%
|
1
100%
|
14
100%
|
Outcome Measures
Title | Number of Participants Experiencing Graft Failure |
---|---|
Description | Graft failure is defined as absolute neutrophil count( ANC ) <5 x 10^8/L by day 30. |
Time Frame | Day 30 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants Experiencing Chronic Graft-Versus-Host Disease |
---|---|
Description | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. |
Time Frame | Day 42 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants Experiencing Chronic Graft-Versus-Host Disease |
---|---|
Description | Chronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cellsinto a foreign host. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants Experiencing Acute Graft-Versus-Host Disease |
---|---|
Description | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. |
Time Frame | 1 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
Title | Number of Participants Experiencing Acute Graft-Versus-Host Disease |
---|---|
Description | Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host. |
Time Frame | Day 42 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants Experiencing Relapse |
---|---|
Description | Patients with leukemia will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. |
Time Frame | 1 Year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
0
0%
|
2
25%
|
1
50%
|
0
0%
|
Title | Number of Participants Experiencing Overall Survival |
---|---|
Description | Overall Survival - Number of patients alive at 1 year post transplant |
Time Frame | 1 Year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
1
33.3%
|
4
50%
|
1
50%
|
1
100%
|
Title | Number of Participants Experiencing Major Infections |
---|---|
Description | Number of participants experiencing Major Infections by the end of treatment |
Time Frame | Day 1 through 1 year post-transplant |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS |
---|---|---|---|---|
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system |
Measure Participants | 3 | 8 | 2 | 1 |
Count of Participants [Participants] |
3
100%
|
8
100%
|
2
100%
|
1
100%
|
Adverse Events
Time Frame | 1 year | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS | ||||
Arm/Group Description | Bone marrow processed using Isolex300i | No processing | Bone marrow processed using CliniMACS | sibling donor without use of CliniMACS system | ||||
All Cause Mortality |
||||||||
Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/3 (66.7%) | 4/8 (50%) | 1/2 (50%) | 0/1 (0%) | ||||
Serious Adverse Events |
||||||||
Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/3 (66.7%) | 2/8 (25%) | 1/2 (50%) | 0/1 (0%) | ||||
General disorders | ||||||||
Primary Graft Failure | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Death | 2/3 (66.7%) | 2 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Relapse | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
diffuse alveolar hemorrhage | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
Marrow Isolex | USB Arm | Marrow Clinimacs | Sibling withoutCliniMACS | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/3 (100%) | 7/8 (87.5%) | 2/2 (100%) | 1/1 (100%) | ||||
Blood and lymphatic system disorders | ||||||||
Coagulopathy | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Disseminated intravascular coagulation | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Cardiac disorders | ||||||||
pericardial effusion | 0/3 (0%) | 0 | 1/8 (12.5%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Ear and labyrinth disorders | ||||||||
hearing loss | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Eosinophilic gut | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
GI bleeding | 1/3 (33.3%) | 1 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Pneumoperitoneum | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
General disorders | ||||||||
Drug Rash with Eosinophilia | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Engraftment syndrome | 0/3 (0%) | 0 | 2/8 (25%) | 3 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Primary Graft Failure | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Hepatobiliary disorders | ||||||||
Veno occlusive disease | 1/3 (33.3%) | 1 | 2/8 (25%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Infections and infestations | ||||||||
Infection | 3/3 (100%) | 18 | 6/8 (75%) | 18 | 1/2 (50%) | 1 | 1/1 (100%) | 1 |
Pneumonia | 1/3 (33.3%) | 1 | 3/8 (37.5%) | 10 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
Thrush | 0/3 (0%) | 0 | 0/8 (0%) | 0 | 1/2 (50%) | 1 | 0/1 (0%) | 0 |
Nervous system disorders | ||||||||
Unresponsive | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Renal and urinary disorders | ||||||||
Acute kidney injury | 0/3 (0%) | 0 | 2/8 (25%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Dialysis | 1/3 (33.3%) | 1 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Renal failure | 1/3 (33.3%) | 1 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Acute hypoxic respiratory failure | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
acute respiratory distress syndrome | 1/3 (33.3%) | 1 | 0/8 (0%) | 0 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Intubation | 2/3 (66.7%) | 2 | 2/8 (25%) | 2 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
pulmonary hemorrhage | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Respiratory distress syndrome | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Surgical and medical procedures | ||||||||
Chest Tube Placement | 1/3 (33.3%) | 1 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Chest Xray | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Pleuracentesis | 0/3 (0%) | 0 | 1/8 (12.5%) | 1 | 0/2 (0%) | 0 | 0/1 (0%) | 0 |
Vascular disorders | ||||||||
Hypertension | 0/3 (0%) | 0 | 2/8 (25%) | 2 | 1/2 (50%) | 1 | 1/1 (100%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Margaret L. MacMillan, M.D. |
---|---|
Organization | Masonic Cancer Center, University of Minnesota |
Phone | 612-273-2800 |
macmi002@umn.edu |
- 2002LS014
- MT2002-02
- 0202M18741