Donor Stem Cell Transplant in Treating Patients With Myeloid Cancer or Other Disease

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00392782
• Collaborator: Center for International Blood and Marrow Transplant Research (Other)
• Enrollment: 24
• Locations: 9
• Arm: 1
• Duration (Months): 70
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Giving total-body irradiation and chemotherapy, such as fludarabine and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with myeloid cancer or other disease.

Condition or Disease	Intervention/Treatment	Phase
Leukemia; Myelodysplastic Syndromes	Biological: anti-thymocyte globulin; Drug: fludarabine phosphate; Drug: thiotepa; Procedure: peripheral blood stem cell transplantation; Radiation: total-body irradiation	Phase 2

Detailed Description

OBJECTIVES:

Primary

• Determine the incidence of disease-free survival at 1 year in patients with acute or chronic myeloid leukemias undergoing T-cell-depleted hematopoietic stem cell transplantation from HLA-C mismatched, unrelated donors.

Secondary

• Determine the incidence of disease relapse at 1 year in patients treated with this regimen.

• Determine the incidence and severity of acute graft-vs-host disease (GVHD) at 100 days and chronic GVHD at 1 year in these patients.

• Determine the incidence of graft failure at day 100.

• Determine the transplant-related mortality of these patients at 1 year.

• Determine the overall survival of these patients at 1 year.

OUTLINE: This is a prospective, multicenter study. Patients are stratified according to killer-cell immunoglobulin-like receptors (KIR) epitope mismatch (yes [experimental] vs no [control]).

• Myeloablative preparative regimen: Patients undergo total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.

• Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.

After completion of study treatment, patients are followed periodically for at least 1 year.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Prospective Trial to Evaluate the Role of NK Cell KIR Epitope Mismatch on Mortality and Disease Relapse in T-Cell Depleted Hematopoietic Stem Cell Transplantation From HLA-C Mismatched, Unrelated Donors for Myeloid Malignancies
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Natural Killer Cell Kir Epitope

Biological: anti-thymocyte globulin; Rabbit thymoglobulin will be given intravenously at a dose of 2.5 mg/kg on days -5,-4, -3, and -2. The first dose of thymoglobulin will be given over six (6) hours and subsequent doses over four (4) or more hours as tolerated or, per institutional anti-thymocyte globulin (ATG) administration guidelines.; Other Names: ATG ; Drug: fludarabine phosphate; Fludarabine 40 mg/m^2/day intravenously (IV) over 30-60 minutes on days -7,-6,-5,-4,-3 (total dose 200 mg/m^2).; Other Names: Fludara ; Drug: thiotepa; Thiotepa 5 mg/kg/day intravenously (IV) over 4 hours on days -8, -7 (total dose 10 mg/kg).; Procedure: peripheral blood stem cell transplantation; Peripheral Blood Stem Cell (PBSC) Infusion. All patients will receive granulocyte colony-stimulating factor (G-CSF)-mobilized PBSC on day 0 (or day+1 when available) following CD34 cell selection for ex vivo T cell removal. PBSC is infused via a central venous catheter using blood infusion tubing.; Other Names: PBSC ; Radiation: total-body irradiation; The total-body irradiation (TBI) will be given in 2 fractions of 400 cGy each administered on day -10 and -9 via anterior and posterior fields for a total dose of 800 cGy.; Other Names: TBI

Outcome Measures

Primary Outcome Measures

1. Incidence of Disease-free Survival [1 Year]

   Number of patients alive and without disease at 1 year after transplant.

Secondary Outcome Measures

1. Incidence of Disease Relapse [1 Year]

   Number of patients with disease at 1 year.

2. Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD) [Day 100]

   Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening.

3. Incidence of Chronic Graft-versus-host Disease (GVHD) [1 Year]

   Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD.

4. Incidence of Graft Failure [Day 100]

   Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.

5. Transplant-related Mortality [1 Year]

   Number of patients with treatment related death at 1 year post transplant.

6. Overall Survival [1 Year]

   Number of patients who were deceased at 1 year post transplant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Primary acute myeloid leukemia (AML)

• First complete remission (CR) with high risk features as defined by: failure to achieve remission by day 21 after induction chemotherapy, or the presence of chromosomal abnormalities involving any of the following: -5/de (5q), -7/del(7q), inversion 3q, abnormalities of 11q23, 20q, 21q, del(9q), translocation 6;9, translocation 9;22, abnormalities of 17p, or complex karyotype with > or = 3 abnormalities. Complete remission is defined as < 5% blasts in the marrow.

• Second CR or subsequent in remission

• Refractory or relapsed disease with absolute peripheral blood blasts < 2000/mcL

• Secondary AML in remission or relapse

• Chronic myelogenous leukemia (CML) in accelerated or blast phase

• Accelerated phase is defined by any one of the following:

• Blasts 10% to 19% of peripheral blood white cells or bone marrow cells

• Peripheral blood basophils at least 20%

• Persistent thrombocytopenia (<100 x 10^{9/L) unrelated to therapy, or persistent thrombocytosis (>1000 x 10}9/L) unresponsive to therapy

• Increasing spleen size and increasing white blood cell (WBC) count unresponsive to therapy

• Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase CML)

• Resistance to tyrosine kinase inhibitors (imatinib or other) defined as no complete cytogenetic response even if the above criteria are not met.

• Blast phase is defined by either of the following:

• Blasts 20% or more of peripheral blood white cells or bone marrow cells

• Extramedullary blast proliferation

• Large foci or clusters of blasts in bone marrow biopsy

• Primary myelodysplastic syndrome (MDS) with an IPSS score >1

• Secondary MDS with any international prostate symptom score (IPSS)

• Age ≤60 years

• Co-Morbidity score 0-2

• At least 35 days following start of preceding leukemia induction therapy

Exclusion Criteria:

• Patients for whom a suitable HLA genotypically identical sibling or fully matched HLA-A, -B, -C, and -DRB1 unrelated donor is available.

• Patients greater than 60 years of age.

• Hypersensitivity to thymoglobulin.

• Symptomatic uncontrolled coronary artery disease or congestive heart failure.

• Hepatic disease with transaminases or bilirubin > 2 times upper limit of normal (ULN) except for isolated hyperbilirubinemia attributed to Gilbert's syndrome.

• Severe hypoxemia with room air - Partial Pressure of Oxygen in Arterial Blood - (PAO2) < 70, supplemental oxygen-dependence, or carbon monoxide diffusing capacity (DLCO) < 50% predicted.

• Impaired renal function with creatinine > 2 times upper limit of normal (ULN) or creatinine clearance measured by 24-hour urine collection < 50% normal for age, gender, and weight.

• Patients with central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy.

• Patients who are human immunodeficiency virus (HIV) seropositive.

• Patients who are pregnant or breast-feeding.

• Patients with active infections that are untreated, or failing to respond to appropriate therapy.

• Karnofsky performance status < 50%.

• Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplant.

• Inability to provide informed consent.

• Co-morbidity score >2

• Less than 35 days from start of previous leukemia induction therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612
2	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
3	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202-5289
4	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
5	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
6	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio	United States	43210-1240
7	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
8	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
9	Midwest Children's Cancer Center at Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota
• Center for International Blood and Marrow Transplant Research

Investigators

• Principal Investigator: Daniel J. Weisdorf, MD, Masonic Cancer Center, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT00392782
• Other Study ID Numbers: 2004UC035; UMN-MT2004-04; UMN-0405M59662
• First Posted: Oct 26, 2006
• Last Update Posted: Dec 28, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Masonic Cancer Center, University of Minnesota: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia in remission; childhood acute myeloid leukemia in remission; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); recurrent adult acute myeloid leukemia; recurrent childhood acute myeloid leukemia; secondary acute myeloid leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; childhood chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; secondary myelodysplastic syndromes
• Additional relevant MeSH terms: Leukemia; Preleukemia; Myelodysplastic Syndromes; Syndrome; Fludarabine; Fludarabine phosphate; Thiotepa; Antilymphocyte Serum

Study Results

Participant Flow

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Period Title: Overall Study
STARTED	24
COMPLETED	24
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Overall Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	24 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.1 (12.9)
Sex: Female, Male (Count of Participants)
Female	13 54.2%
Male	11 45.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 4.2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 25%
White	17 70.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	24 100%
Disease (Number) [Number]
Acute Myeloid Leukemia - CR1	10 41.7%
Acute Myeloid Leukemia - CR2	7 29.2%
Myelodysplastic Syndrome - RAEB2	2 8.3%
Myelodysplastic Syndrome - NOS	1 4.2%
Chronic Myeloid Leukemia	4 16.7%

Outcome Measures

1. Primary Outcome

Title	Incidence of Disease-free Survival
Description	Number of patients alive and without disease at 1 year after transplant.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Measure Participants	24
Number [Participants]	18 75%

2. Secondary Outcome

Title	Incidence of Disease Relapse
Description	Number of patients with disease at 1 year.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Measure Participants	24
Number [Participants]	6 25%

3. Secondary Outcome

Title	Incidence of Grade II-IV Acute Graft-vs-host Disease (GVHD)
Description	Number of patients with grade II-IV acute graft-versus-host disease at Day 100 post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening.
Time Frame	Day 100

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Measure Participants	24
Number [Participants]	6 25%

4. Secondary Outcome

Title	Incidence of Chronic Graft-versus-host Disease (GVHD)
Description	Number of patients with chronic graft-versus-host disease at 1 year post transplant. Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack. Grade I=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening. Chronic GVHD is an extension of acute GVHD.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Measure Participants	24
Number [Participants]	4 16.7%

5. Secondary Outcome

Title	Incidence of Graft Failure
Description	Number of patients with graft failure is defined by lack of neutrophil engraftment by 100 days after transplant in patients surviving a minimum of 14 days.
Time Frame	Day 100

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Measure Participants	24
Number [Participants]	1 4.2%

6. Secondary Outcome

Title	Transplant-related Mortality
Description	Number of patients with treatment related death at 1 year post transplant.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Measure Participants	24
Number [Participants]	8 33.3%

7. Secondary Outcome

Title	Overall Survival
Description	Number of patients who were deceased at 1 year post transplant.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
Measure Participants	24
Number [Participants]	10 41.7%

Adverse Events

Time Frame	Serious adverse events were collected from first date of study treatment up to 1 year post transplant.
Adverse Event Reporting Description	Because all study participants received potentially toxic preparative therapy, significant regimen-related toxicity was anticipated. Therefore only selected adverse events (serious infections, graft failure and GVHD) were collected.
Arm/Group Title	All Treated Patients
Arm/Group Description	Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0.
All Cause Mortality
	All Treated Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Treated Patients
	Affected / at Risk (%)	# Events
Total	23/24 (95.8%)
Blood and lymphatic system disorders
Blood/bone marrow, other	2/24 (8.3%)	2
Low hemoglobin	1/24 (4.2%)	1
Hemolysis	1/24 (4.2%)	1
Infection with Grade 3-4 neutrophils	1/24 (4.2%)	2
Thrombosis	2/24 (8.3%)	2
Cardiac disorders
Cardiac, general	1/24 (4.2%)	1
Pain - cardiac/heart	1/24 (4.2%)	1
Supraventricular and nodal arrhythmia	1/24 (4.2%)	1
Vascular	1/24 (4.2%)	2
Endocrine disorders
Low serum glucose	1/24 (4.2%)	1
Gastrointestinal disorders
Dehydration	1/24 (4.2%)	1
Diarrhea	4/24 (16.7%)	4
Mucositis	1/24 (4.2%)	1
Gastrointestinal obstruction - ureter	1/24 (4.2%)	1
General disorders
Death	3/24 (12.5%)	3
Fatigue	1/24 (4.2%)	1
Gastrointestinal necrosis	1/24 (4.2%)	1
Pain - abdomen	2/24 (8.3%)	2
Progressive disease	1/24 (4.2%)	1
Relapse	2/24 (8.3%)	2
Hepatobiliary disorders
Hyperbilirubinemia	1/24 (4.2%)	1
Cholecystitis	1/24 (4.2%)	1
Immune system disorders
ALT/serum glutamic pyruvic transaminase increased	1/24 (4.2%)	1
Infections and infestations
Infection, other	3/24 (12.5%)	4
Infection with normal neutrophils, lung	1/24 (4.2%)	2
Infection with unknown neutrophils, blood	6/24 (25%)	6
Infection with unknown neutrophils, catheter	2/24 (8.3%)	2
Infection with unknown neutrophils, colon	1/24 (4.2%)	1
Infection w/unknown neutrophils - lung	1/24 (4.2%)	1
Infection w/unknown neutrophils - mucosa	1/24 (4.2%)	1
Infection with unknown neutrophils - upper airway	1/24 (4.2%)	1
Infection with unknown neutrophils - wound	1/24 (4.2%)	1
Injury, poisoning and procedural complications
Fracture	1/24 (4.2%)	1
Nervous system disorders
Cerebrovascular ischemia	1/24 (4.2%)	1
Neurology	1/24 (4.2%)	2
Syncope	1/24 (4.2%)	1
Renal and urinary disorders
Renal	1/24 (4.2%)	1
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome	1/24 (4.2%)	1
Dyspnea	1/24 (4.2%)	1
Hemorrhage, pulmonary/upper respiratory	1/24 (4.2%)	1
Hypoxia	2/24 (8.3%)	2
Pulmonary - upper respiratory	2/24 (8.3%)	2
Skin and subcutaneous tissue disorders
Rash	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	All Treated Patients
	Affected / at Risk (%)	# Events
Total	0/24 (0%)

Limitations/Caveats

[Not Specified]

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.