IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00469144
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 233
• Location: 1
• Arms: 2
• Duration (Months): 113
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulfan dose based on body size, along with a fixed dose of fludarabine. The safety of dosing based on blood levels will also be studied.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome; Leukemia; Acute Myeloid Leukemia	Drug: Busulfan; Drug: Fludarabine	Phase 3

Detailed Description

Busulfan is a chemotherapy drug that kills cancer cells by binding to DNA, and is commonly used in stem cell transplantation. Fludarabine is an antimetabolite drug which has anti-leukemia and immunosuppressive effects.

If you are eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 study groups. One group will receive a fixed dose of busulfan, while the other group will receive an adjusted dose of busulfan based on blood levels of the drug. Both groups will receive fludarabine treatment as well as a stem cell transplant.

Patients in the adjusted-dose group will first receive a low-level "test" dose of busulfan to check how their blood levels change over time; this information will be used to decide the next dose needed to reach the target blood level that matches your body size. Patients in the fixed-dose group will receive a fixed dose of busulfan without the test dose. If you are assigned to the fixed-dose group, this measurement will only affect your dose level if you have an unusually high or low drug level in your blood. Patients in both groups will have a total of about 20 teaspoons (less than 7 tablespoons) of blood drawn over time to check their busulfan blood levels following one or more of the busulfan treatments.

About 11 samples of blood will be drawn to check your blood levels of busulfan over time following the test dose and the first high-dose busulfan treatment; each sample is about 1 teaspoon of blood. A heparin lock will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for these blood level tests to be performed for technical or scheduling reasons, you will receive the standard fixed dose.

Both groups of patients receive fludarabine through a central venous catheter (CVC--a small tube inserted into one of your major veins, usually in the chest or shoulder blade) over 1 hour, once a day, for 4 days. After each dose of fludarabine, the high-dose Busulfan will be infused through the CVC over 3 hours. These drugs are given to try to kill malignant cells and suppress your immune system in order to reduce the risk of stem cell transplant rejection. If you are going to be receiving a transplant from an HLA-type-nonidentical or unrelated donor, you will also receive Thymoglobulin (ATG) over 4 hours on the 3 days prior to the transplant to further suppress your immune system.

After 2 days of rest, the allogeneic stem cells (bone marrow or peripheral blood stem cells) will then be given intravenously (IV--through a needle in your vein). You will receive the drug G-CSF (Neupogen) as an injection under the skin daily starting 1 week after the transplant until your blood cell levels return to normal.

Patients usually remain in the hospital for about 4 weeks after stem cell transplantation. After you are released from the hospital, you will continue as an outpatient in the hospital area to be monitored for infections and transplant-related complications for a minimum of 100 days after the transplant.

Patients who previously had leukemia involvement in the nervous system may need to receive spinal taps, with injection of cytosine arabinoside and hydrocortisone, several times over the year after transplantation to try to keep the leukemia from coming back.

You will undergo blood tests and bone marrow biopsies at 3, 6, and 12 months after the transplant, to check if the disease is in remission. Your health status will be followed along with their local physician to find out if the leukemia or myelodysplastic syndrome comes back, as well as to check the length of your survival.

This is an investigational study. All of the drugs used in this study are approved by the FDA for treatment of cancer. Up to 230 patients will take part in this study. All will be enrolled at MD Anderson.

Study Design

• Study Type: Interventional
• Actual Enrollment: 233 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Study of Once Daily IV Busulfan With Fludarabine With Hemopoietic Stem Cell Transplantation for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fixed-Dose Busulfan + Fludarabine Busulfan Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.	Drug: Busulfan; Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.; Drug: Fludarabine; 40 mg/m^2 IV Daily Over 1 Hour x 4 Days
Experimental: Adjusted Dose Busulfan + Fludarabine Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.	Drug: Busulfan; Fixed Dose = 130 mg/m^2 IV Daily Over Three Hours x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.; Drug: Fludarabine; 40 mg/m^2 IV Daily Over 1 Hour x 4 Days

Outcome Measures

Primary Outcome Measures

1. Treatment-related Mortality (TRM) [From transplant at Day 0 to Day 100 and 1 year following transplant]

   Time to failure (TTF) defined as either disease recurrence or death, from the time of bone marrow transplant (BMT) and reported as TRM at 100 days and 1 year. Treatment period defined as BMT Day -9 for patients treated on the PK-guided treatment arm, and day -7 for patients receiving the fixed-dose busulfan treatment through BMT Day +28. The post study surveillance period is defined as BMT Day +29 through BMT Day +100. Bone marrow aspirate with cytogenetics at approximately one (1) month and three (3) months, or as clinically indicated. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.

2. 3 Year Progression Free Survival [3 years]

   PFS defined as length of time either due to disease recurrence or death, from the time of stem cell infusion (Bone marrow or PBPC) to 3 years. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Acute myeloid leukemia past first remission, in first or subsequent relapse, in first remission (cytogenetics other than t(8;21, inv 16, t(15;17)) or induction failures. Only myeloid leukemia but not biphenotypic leukemia is allowed on this study.

2. Myelodysplastic syndromes with intermediate or high risk International Prognostic Scoring System score

3. Patient has not been administered any other systemic chemotherapeutic drug (including Mylotarg) within 21 days prior to trial enrollment (BMT Day -7 or day -9 for the test-dose arm of the study). Hydroxyurea is permitted if indicated to control induction refractory disease, and IT chemotherapy is allowed if indicated as maintenance treatment for previously diagnosed leptomeningeal disease, that has been in remission for at least 3 months prior to enrollment on this study).

4. No active infection. Protocol PI will be final arbiter if there is uncertainty regarding whether a previous infection is resolved.

5. age <=65

6. Patients must have a matched related or unrelated donor willing to donate. A donor who is HLA identical or mismatched in 1 locus on Class I [HLA, A or B], or molecularly mismatched in 1 locus on Class II [HLA, DR or DQ] is also acceptable.

7. ZUBROD performance status <2

8. Life expectancy is not severely limited by concomitant illness and expected to be >12 weeks.

9. Left ventricular ejection fraction >45% No uncontrolled arrhythmias or symptomatic cardiac disease.

10. No symptomatic pulmonary disease. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO)

/= 50% of expected corrected for hemoglobin. In patients </= 7 years pulmonary function will be assessed per pediatric BMT routine

1. Serum creatinine </= 1.5 mg%.

2. Serum glutamate pyruvate transaminase (SGPT) </= 200 IU/ml, serum bilirubin and alkaline phosphatase within accepted laboratory standard normal limits or considered not clinically significant. No evidence of chronic active hepatitis or cirrhosis. If positive hepatitis serology, discuss with Study Chairman and consider liver biopsy.

3. No effusion or ascites >1L prior to drainage.

4. HIV-negative.

5. Female patient is not pregnant (negative B-human chorionic gonadotropin (HCG) pregnancy test in all women of child-bearing-potential in accordance with departmental routine).

6. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.

7. No prior autologous stem cell transplants

Exclusion Criteria:

1. None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Richard E. Champlin, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00469144
• Other Study ID Numbers: 2005-0366; NCI-2012-01475; CA55164
• First Posted: May 4, 2007
• Last Update Posted: Jan 19, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by M.D. Anderson Cancer Center: Stem Cell Transplantation; Leukemia; Busulfan; Fludarabine; MDS; AML
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myeloid; Myelodysplastic Syndromes; Syndrome; Fludarabine; Busulfan

Study Results

Participant Flow

Recruitment Details	Recruitment Period: June 28, 2005 to May 12, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Detail	A total of 233 participants were enrolled, out of which 8 participants withdrew from study prior to treatment and are not evaluable on protocol.

Arm/Group Title	Fixed-Dose Busulfan + Fludarabine	Adjusted Dose Busulfan + Fludarabine
Arm/Group Description	Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.	Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
Period Title: Overall Study
STARTED	114	111
COMPLETED	108	105
NOT COMPLETED	6	6

Baseline Characteristics

Arm/Group Title	Fixed-Dose Busulfan + Fludarabine	Adjusted Dose Busulfan + Fludarabine	Total
Arm/Group Description	Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.	Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.	Total of all reporting groups
Overall Participants	114	111	225
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	52	50	50
Sex: Female, Male (Count of Participants)
Female	55 48.2%	56 50.5%	111 49.3%
Male	59 51.8%	55 49.5%	114 50.7%
Region of Enrollment (participants) [Number]
United States	114 100%	111 100%	225 100%

Outcome Measures

1. Primary Outcome

Title	Treatment-related Mortality (TRM)
Description	Time to failure (TTF) defined as either disease recurrence or death, from the time of bone marrow transplant (BMT) and reported as TRM at 100 days and 1 year. Treatment period defined as BMT Day -9 for patients treated on the PK-guided treatment arm, and day -7 for patients receiving the fixed-dose busulfan treatment through BMT Day +28. The post study surveillance period is defined as BMT Day +29 through BMT Day +100. Bone marrow aspirate with cytogenetics at approximately one (1) month and three (3) months, or as clinically indicated. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.
Time Frame	From transplant at Day 0 to Day 100 and 1 year following transplant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fixed-Dose: Participants in CR	Adjusted Dose: Participants in CR	Fixed Dose: Participants Not in CR	Adjusted Dose: Participants Not in CR
Arm/Group Description	Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.	Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.	Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.	Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
Measure Participants	68	71	46	40
100 Days	3 2.6%	3 2.7%	7 3.1%	3 NaN
1 Year	19 16.7%	17 15.3%	18 8%	3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Fixed-Dose: Participants in CR, Adjusted Dose: Participants in CR
	Comments	100 Days, Between Arms: Participants in CR
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.9
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fixed Dose: Participants Not in CR, Adjusted Dose: Participants Not in CR
	Comments	100 Days, Between Arms: Participants not in CR
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.4
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fixed-Dose: Participants in CR, Adjusted Dose: Participants in CR
	Comments	1 Year, Between Arms: Participants in CR
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Fixed Dose: Participants Not in CR, Adjusted Dose: Participants Not in CR
	Comments	1 Year, Between Arms: Participants not in CR
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	3 Year Progression Free Survival
Description	PFS defined as length of time either due to disease recurrence or death, from the time of stem cell infusion (Bone marrow or PBPC) to 3 years. Response Criteria is measured by the bone marrow aspirate to determine it has leukemic blast. Bone marrow blast less than 5% is considered to be a complete response.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fixed-Dose Busulfan + Fludarabine	Adjusted Dose Busulfan + Fludarabine
Arm/Group Description	Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.	Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
Measure Participants	114	111
Median (Full Range) [Days]	42	56

Adverse Events

Time Frame	Adverse events collected from BMT Day -7 through BMT Day +28 or the day of discharge from the in-patient unit and post-study surveillance from initial discharge to BMT Day +100. The end of active treatment is the day of the allogeneic stem cell infusion.
Adverse Event Reporting Description	Overall AE collection period: July 21, 2005 to October 27, 2014.
Arm/Group Title	Fixed-Dose Busulfan + Fludarabine		Adjusted Dose Busulfan + Fludarabine
Arm/Group Description	Busulfan Fixed Dose = 130 mg/m^2 intravenous (IV) Daily Over Three Hours x 4 Days. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days.		Busulfan Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day. Fludarabine 40 mg/m^2 IV Daily Over 1 Hour x 4 Days. Adjusted Dose = 32 mg/m^2 IV Over 2 Hours Test Dose x 1 Day; Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
All Cause Mortality
	Fixed-Dose Busulfan + Fludarabine		Adjusted Dose Busulfan + Fludarabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Fixed-Dose Busulfan + Fludarabine		Adjusted Dose Busulfan + Fludarabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/114 (1.8%)		3/111 (2.7%)
General disorders
Death	1/114 (0.9%)	1	2/111 (1.8%)	2
Nervous system disorders
Encephalopathy	1/114 (0.9%)	1	0/111 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	0/114 (0%)	0	1/111 (0.9%)	1
Respiratory Failure	1/114 (0.9%)	1	0/111 (0%)	0
Other (Not Including Serious) Adverse Events
	Fixed-Dose Busulfan + Fludarabine		Adjusted Dose Busulfan + Fludarabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/114 (25.4%)		26/111 (23.4%)
Blood and lymphatic system disorders
Thrombocytopenia	0/114 (0%)	0	1/111 (0.9%)	1
Eye disorders
Chronic Ocular GvHD	3/114 (2.6%)	3	1/111 (0.9%)	1
Ocular GvHD	1/114 (0.9%)	1	3/111 (2.7%)	3
Blurry Vision	0/114 (0%)	0	1/111 (0.9%)	1
Gastrointestinal disorders
Chronic Oral GvHD	2/114 (1.8%)	2	1/111 (0.9%)	1
Esophageal Dysmotility	1/114 (0.9%)	1	0/111 (0%)	0
Oral GvHD	2/114 (1.8%)	2	2/111 (1.8%)	2
GI GvHD	1/114 (0.9%)	1	1/111 (0.9%)	1
Upper GI GvHD	0/114 (0%)	0	1/111 (0.9%)	1
General disorders
Fever	0/114 (0%)	0	1/111 (0.9%)	1
Hepatobiliary disorders
Liver GvHD	3/114 (2.6%)	3	2/111 (1.8%)	2
Immune system disorders
Autoimmune Hemolytic Anemia	0/114 (0%)	0	1/111 (0.9%)	1
Infections and infestations
Beta Hemolytic Streptococcus Upper Respiratory Infection	1/114 (0.9%)	1	0/111 (0%)	0
Streptococcus Pneumonia	1/114 (0.9%)	1	0/111 (0%)	0
Cytomegalovirus Pneumonia	1/114 (0.9%)	1	0/111 (0%)	0
Respiratory Syncytial Virus Upper Respiratory Infection	1/114 (0.9%)	1	2/111 (1.8%)	2
Methicillin-Resistant Staphylococcus Aureus Pneumonia	0/114 (0%)	0	1/111 (0.9%)	1
Influenza A Upper Respiratory Infection	0/114 (0%)	0	1/111 (0.9%)	1
Infection	10/114 (8.8%)	11	5/111 (4.5%)	5
BK Virus	0/114 (0%)	0	1/111 (0.9%)	1
Aspergillus Pneumonia	0/114 (0%)	0	1/111 (0.9%)	1
Herpes Simplex Virus	1/114 (0.9%)	1	1/111 (0.9%)	1
Influenza B Upper Respiratory Infection	0/114 (0%)	0	1/111 (0.9%)	1
Cytomegalovirus Reactivation	1/114 (0.9%)	1	2/111 (1.8%)	2
Micrococcus Line Infection	0/114 (0%)	0	1/111 (0.9%)	1
Parainfluenza Upper Respiratory Infection	0/114 (0%)	0	1/111 (0.9%)	1
Pseudomonas Aeruginosa/Enterococcus Urinary Tract Infection	0/114 (0%)	0	2/111 (1.8%)	2
Clostridum Difficile	0/114 (0%)	0	1/111 (0.9%)	1
Enterococcus Faecalis Line Infection	0/114 (0%)	0	1/111 (0.9%)	1
Herpes Simplex Virus Esophagitis	0/114 (0%)	0	1/111 (0.9%)	1
Alpha Hemolytic Strep Line Infection	0/114 (0%)	0	1/111 (0.9%)	1
Urinary Tract Infection	0/114 (0%)	0	1/111 (0.9%)	1
Parainfluenza Pneumonia	1/114 (0.9%)	1	0/111 (0%)	0
Fungal Pneumonia	1/114 (0.9%)	1	0/111 (0%)	0
Influenza A Virus Pneumonia	2/114 (1.8%)	2	0/111 (0%)	0
Herpes Simplex Virus Oral Lesion	1/114 (0.9%)	1	0/111 (0%)	0
Invasive Candida Glabrata/Fusarium Sinusitis	1/114 (0.9%)	1	0/111 (0%)	0
Escherichia Coli Urinary Tract Infection	1/114 (0.9%)	1	0/111 (0%)	0
Branhamella Catarrhalis Upper Respiratory Infection	1/114 (0.9%)	1	0/111 (0%)	0
Corynebacterium/Bacil/Microbacterium Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Stenotrophomonas Maltophilia Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Epstein-Barr Virus	1/114 (0.9%)	1	0/111 (0%)	0
Methicillin-Resistant Staphylococcus Aureus Urinary Tract Infection	1/114 (0.9%)	1	0/111 (0%)	0
Parvovirus Viremia	1/114 (0.9%)	1	0/111 (0%)	0
Pseudomonas Aeruginosa Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Herpes Zoster Eruption	1/114 (0.9%)	1	0/111 (0%)	0
Bacteremia	1/114 (0.9%)	1	1/111 (0.9%)	1
Acinetobacter Calcoaceticus Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Human Herpes Virus-6	2/114 (1.8%)	2	0/111 (0%)	0
Klebsiella Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Enterococcus Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Acinetobacter Ursingii Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Parovirus B19	1/114 (0.9%)	1	0/111 (0%)	0
Stenotrophomonas (Xanthomonas) Bacteremia	1/114 (0.9%)	1	0/111 (0%)	0
Bacillus Species Pneumonia	1/114 (0.9%)	1	0/111 (0%)	0
Metabolism and nutrition disorders
Creatinine	1/114 (0.9%)	1	2/111 (1.8%)	2
Bilirubin	0/114 (0%)	0	1/111 (0.9%)	1
Musculoskeletal and connective tissue disorders
Hand-Foot Syndrome	0/114 (0%)	0	1/111 (0.9%)	1
Renal and urinary disorders
Renal Insufficiency	1/114 (0.9%)	1	0/111 (0%)	0
Hemorrhagic Cystitis	1/114 (0.9%)	1	1/111 (0.9%)	1
Reproductive system and breast disorders
Chronic Vaginal GvHD	1/114 (0.9%)	1	0/111 (0%)	0
Vagina GvHD	1/114 (0.9%)	1	0/111 (0%)	0
Vulva GvHD	0/114 (0%)	0	1/111 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Chronic Lung GvHD	0/114 (0%)	0	1/111 (0.9%)	1
Pneumonitis	2/114 (1.8%)	2	1/111 (0.9%)	1
Lung GvHD	1/114 (0.9%)	1	1/111 (0.9%)	1
Pneumonia	0/114 (0%)	0	3/111 (2.7%)	3
Aspiration Pneumonitis	1/114 (0.9%)	1	0/111 (0%)	0
Skin and subcutaneous tissue disorders
Pruritis	1/114 (0.9%)	1	1/111 (0.9%)	1
Chronic Skin GvHD	1/114 (0.9%)	1	3/111 (2.7%)	3
Skin GvHD	6/114 (5.3%)	6	1/111 (0.9%)	1
Rash	1/114 (0.9%)	1	0/111 (0%)	0
Dermatitis	0/114 (0%)	0	1/111 (0.9%)	1
Surgical and medical procedures
Engraftment Syndrome	1/114 (0.9%)	1	1/111 (0.9%)	1
Vascular disorders
Pulmonary Embolism	0/114 (0%)	0	1/111 (0.9%)	1
Periorbital Hemorrhage	1/114 (0.9%)	1	0/111 (0%)	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.