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)
233
Enrollment
1
Location
2
Arms
113
Duration (Months)
2.1
Patients Per Site Per Month

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.

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

ArmIntervention/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

SiteCityStateCountryPostal Code
1University of Texas MD Anderson Cancer CenterHoustonTexasUnited States77030

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:

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

Study Results

Participant Flow

Recruitment DetailsRecruitment Period: June 28, 2005 to May 12, 2011. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment DetailA 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 TitleFixed-Dose Busulfan + FludarabineAdjusted Dose Busulfan + Fludarabine
Arm/Group DescriptionBusulfan 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
STARTED114111
COMPLETED108105
NOT COMPLETED66

Baseline Characteristics

Arm/Group TitleFixed-Dose Busulfan + FludarabineAdjusted Dose Busulfan + FludarabineTotal
Arm/Group DescriptionBusulfan 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 Participants114111225
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
TitleTreatment-related Mortality (TRM)
DescriptionTime 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 FrameFrom transplant at Day 0 to Day 100 and 1 year following transplant

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleFixed-Dose: Participants in CRAdjusted Dose: Participants in CRFixed Dose: Participants Not in CRAdjusted Dose: Participants Not in CR
Arm/Group DescriptionBusulfan 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 Participants68714640
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 Hypothesisp-Value0.9
Comments
MethodWilcoxon (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 Hypothesisp-Value0.4
Comments
MethodWilcoxon (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 Hypothesisp-Value0.7
Comments
MethodWilcoxon (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 Hypothesisp-Value0.05
Comments
MethodWilcoxon (Mann-Whitney)
Comments
2. Primary Outcome
Title3 Year Progression Free Survival
DescriptionPFS 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 Frame3 years

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleFixed-Dose Busulfan + FludarabineAdjusted Dose Busulfan + Fludarabine
Arm/Group DescriptionBusulfan 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 Participants114111
Median (Full Range) [Days]
42
56

Adverse Events

Time FrameAdverse 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 TitleFixed-Dose Busulfan + FludarabineAdjusted Dose Busulfan + Fludarabine
Arm/Group DescriptionBusulfan 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 + FludarabineAdjusted Dose Busulfan + Fludarabine
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN)
Serious Adverse Events
Fixed-Dose Busulfan + FludarabineAdjusted Dose Busulfan + Fludarabine
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/114 (1.8%) 3/111 (2.7%)
General disorders
Death1/114 (0.9%) 12/111 (1.8%) 2
Nervous system disorders
Encephalopathy1/114 (0.9%) 10/111 (0%) 0
Respiratory, thoracic and mediastinal disorders
Respiratory Failure0/114 (0%) 01/111 (0.9%) 1
Respiratory Failure1/114 (0.9%) 10/111 (0%) 0
Other (Not Including Serious) Adverse Events
Fixed-Dose Busulfan + FludarabineAdjusted Dose Busulfan + Fludarabine
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total29/114 (25.4%) 26/111 (23.4%)
Blood and lymphatic system disorders
Thrombocytopenia0/114 (0%) 01/111 (0.9%) 1
Eye disorders
Chronic Ocular GvHD3/114 (2.6%) 31/111 (0.9%) 1
Ocular GvHD1/114 (0.9%) 13/111 (2.7%) 3
Blurry Vision0/114 (0%) 01/111 (0.9%) 1
Gastrointestinal disorders
Chronic Oral GvHD2/114 (1.8%) 21/111 (0.9%) 1
Esophageal Dysmotility1/114 (0.9%) 10/111 (0%) 0
Oral GvHD2/114 (1.8%) 22/111 (1.8%) 2
GI GvHD1/114 (0.9%) 11/111 (0.9%) 1
Upper GI GvHD0/114 (0%) 01/111 (0.9%) 1
General disorders
Fever0/114 (0%) 01/111 (0.9%) 1
Hepatobiliary disorders
Liver GvHD3/114 (2.6%) 32/111 (1.8%) 2
Immune system disorders
Autoimmune Hemolytic Anemia0/114 (0%) 01/111 (0.9%) 1
Infections and infestations
Beta Hemolytic Streptococcus Upper Respiratory Infection1/114 (0.9%) 10/111 (0%) 0
Streptococcus Pneumonia1/114 (0.9%) 10/111 (0%) 0
Cytomegalovirus Pneumonia1/114 (0.9%) 10/111 (0%) 0
Respiratory Syncytial Virus Upper Respiratory Infection1/114 (0.9%) 12/111 (1.8%) 2
Methicillin-Resistant Staphylococcus Aureus Pneumonia0/114 (0%) 01/111 (0.9%) 1
Influenza A Upper Respiratory Infection0/114 (0%) 01/111 (0.9%) 1
Infection10/114 (8.8%) 115/111 (4.5%) 5
BK Virus0/114 (0%) 01/111 (0.9%) 1
Aspergillus Pneumonia0/114 (0%) 01/111 (0.9%) 1
Herpes Simplex Virus1/114 (0.9%) 11/111 (0.9%) 1
Influenza B Upper Respiratory Infection0/114 (0%) 01/111 (0.9%) 1
Cytomegalovirus Reactivation1/114 (0.9%) 12/111 (1.8%) 2
Micrococcus Line Infection0/114 (0%) 01/111 (0.9%) 1
Parainfluenza Upper Respiratory Infection0/114 (0%) 01/111 (0.9%) 1
Pseudomonas Aeruginosa/Enterococcus Urinary Tract Infection0/114 (0%) 02/111 (1.8%) 2
Clostridum Difficile0/114 (0%) 01/111 (0.9%) 1
Enterococcus Faecalis Line Infection0/114 (0%) 01/111 (0.9%) 1
Herpes Simplex Virus Esophagitis0/114 (0%) 01/111 (0.9%) 1
Alpha Hemolytic Strep Line Infection0/114 (0%) 01/111 (0.9%) 1
Urinary Tract Infection0/114 (0%) 01/111 (0.9%) 1
Parainfluenza Pneumonia1/114 (0.9%) 10/111 (0%) 0
Fungal Pneumonia1/114 (0.9%) 10/111 (0%) 0
Influenza A Virus Pneumonia2/114 (1.8%) 20/111 (0%) 0
Herpes Simplex Virus Oral Lesion1/114 (0.9%) 10/111 (0%) 0
Invasive Candida Glabrata/Fusarium Sinusitis1/114 (0.9%) 10/111 (0%) 0
Escherichia Coli Urinary Tract Infection1/114 (0.9%) 10/111 (0%) 0
Branhamella Catarrhalis Upper Respiratory Infection1/114 (0.9%) 10/111 (0%) 0
Corynebacterium/Bacil/Microbacterium Bacteremia1/114 (0.9%) 10/111 (0%) 0
Stenotrophomonas Maltophilia Bacteremia1/114 (0.9%) 10/111 (0%) 0
Epstein-Barr Virus1/114 (0.9%) 10/111 (0%) 0
Methicillin-Resistant Staphylococcus Aureus Urinary Tract Infection1/114 (0.9%) 10/111 (0%) 0
Parvovirus Viremia1/114 (0.9%) 10/111 (0%) 0
Pseudomonas Aeruginosa Bacteremia1/114 (0.9%) 10/111 (0%) 0
Herpes Zoster Eruption1/114 (0.9%) 10/111 (0%) 0
Bacteremia1/114 (0.9%) 11/111 (0.9%) 1
Acinetobacter Calcoaceticus Bacteremia1/114 (0.9%) 10/111 (0%) 0
Human Herpes Virus-62/114 (1.8%) 20/111 (0%) 0
Klebsiella Bacteremia1/114 (0.9%) 10/111 (0%) 0
Enterococcus Bacteremia1/114 (0.9%) 10/111 (0%) 0
Acinetobacter Ursingii Bacteremia1/114 (0.9%) 10/111 (0%) 0
Parovirus B191/114 (0.9%) 10/111 (0%) 0
Stenotrophomonas (Xanthomonas) Bacteremia1/114 (0.9%) 10/111 (0%) 0
Bacillus Species Pneumonia1/114 (0.9%) 10/111 (0%) 0
Metabolism and nutrition disorders
Creatinine1/114 (0.9%) 12/111 (1.8%) 2
Bilirubin0/114 (0%) 01/111 (0.9%) 1
Musculoskeletal and connective tissue disorders
Hand-Foot Syndrome0/114 (0%) 01/111 (0.9%) 1
Renal and urinary disorders
Renal Insufficiency1/114 (0.9%) 10/111 (0%) 0
Hemorrhagic Cystitis1/114 (0.9%) 11/111 (0.9%) 1
Reproductive system and breast disorders
Chronic Vaginal GvHD1/114 (0.9%) 10/111 (0%) 0
Vagina GvHD1/114 (0.9%) 10/111 (0%) 0
Vulva GvHD0/114 (0%) 01/111 (0.9%) 1
Respiratory, thoracic and mediastinal disorders
Chronic Lung GvHD0/114 (0%) 01/111 (0.9%) 1
Pneumonitis2/114 (1.8%) 21/111 (0.9%) 1
Lung GvHD1/114 (0.9%) 11/111 (0.9%) 1
Pneumonia0/114 (0%) 03/111 (2.7%) 3
Aspiration Pneumonitis1/114 (0.9%) 10/111 (0%) 0
Skin and subcutaneous tissue disorders
Pruritis1/114 (0.9%) 11/111 (0.9%) 1
Chronic Skin GvHD1/114 (0.9%) 13/111 (2.7%) 3
Skin GvHD6/114 (5.3%) 61/111 (0.9%) 1
Rash1/114 (0.9%) 10/111 (0%) 0
Dermatitis0/114 (0%) 01/111 (0.9%) 1
Surgical and medical procedures
Engraftment Syndrome1/114 (0.9%) 11/111 (0.9%) 1
Vascular disorders
Pulmonary Embolism0/114 (0%) 01/111 (0.9%) 1
Periorbital Hemorrhage1/114 (0.9%) 10/111 (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.

Results Point of Contact

Name/TitleRichard E. Champlin, MD/Chair, Stem Cell Transplantation
OrganizationUniversity of Texas (UT) MD Anderson Cancer Center
Phone713-792-3618
Emailrchampli@mdanderson.org
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