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Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00593554
Recruitment Status : Terminated (Slow accrual)
First Posted : January 15, 2008
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sherif S. Farag, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplasia
Chronic Myeloid Leukemia
Interventions Radiation: Total Body Irradiation
Drug: Thiotepa
Drug: Fludarabine
Biological: Rabbit ATG
Drug: Palifermin
Enrollment 9
Recruitment Details This protocol had 9 enrolled patients, but one patient never received a transplant nor was randomized. There had been no efficacy or safety data entered for this patient, and they are excluded from the results.
Pre-assignment Details  
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
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Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Period Title: Overall Study
Started 3 5
Completed 0 0
Not Completed 3 5
Reason Not Completed
Death             1             2
Physician Decision             0             1
Withdrawal by Subject             1             0
Disease Progression             1             2
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin Total
Hide Arm/Group Description

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Total of all reporting groups
Overall Number of Baseline Participants 3 5 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
5
 100.0%
8
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 8 participants
42.6  (13.73) 45.9  (12.21) 44.6  (11.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 8 participants
Female
0
   0.0%
1
  20.0%
1
  12.5%
Male
3
 100.0%
4
  80.0%
7
  87.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 8 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
5
 100.0%
8
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 8 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  33.3%
2
  40.0%
3
  37.5%
White
2
  66.7%
3
  60.0%
5
  62.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation
Hide Description To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had treatment-related mortality within 6 months of their transplant is presented.
Time Frame thru 6 months after transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received a transplant
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Overall Number of Participants Analyzed 3 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
33
(0 to 91)
0
(0 to 0)
2.Secondary Outcome
Title Regimen-related Toxicity
Hide Description The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received a transplant
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Overall Number of Participants Analyzed 3 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Time to Neutrophil Engraftment
Hide Description Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidence intervals will be provided.
Time Frame Transplant (Day 0) up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received a transplant
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Overall Number of Participants Analyzed 3 5
Median (95% Confidence Interval)
Unit of Measure: days
15
(11 to 23)
14
(7 to 28)
4.Secondary Outcome
Title Time to Platelet Engraftment
Hide Description Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x109/l without transfusion support. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.
Time Frame Transplant (Day 0) up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received a transplant and who achieved platelet recovery/engraftment of platelets
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Overall Number of Participants Analyzed 3 5
Median (95% Confidence Interval)
Unit of Measure: days
22.5
(17 to 28)
20
(14 to 73)
5.Secondary Outcome
Title Acute Graft vs. Host Disease (GvHD)
Hide Description Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received a transplant
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Overall Number of Participants Analyzed 3 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Chronic Graft vs. Host Disease (GvHD)
Hide Description Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received a transplant
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Overall Number of Participants Analyzed 3 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Frequency of Infection
Hide Description Number of unique patients with bacterial and/or viral infections reported.
Time Frame Day 0 through 1 year post transplantation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients who received a transplant
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description:

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

Overall Number of Participants Analyzed 3 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  66.7%
5
 100.0%
Time Frame Up to 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Without Paliferim Treatment With Palifermin
Hide Arm/Group Description

Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Total Body Irradiation: 8 Gy on Day -9

Thiotepa: 5 mg/kg/d on Day -8 to -7

Fludarabine: 40 mg/m2/d on Day -6 to -3

Rabbit ATG: 2.5 mg/kg/d on Day -5 to -2

Palifermin: 60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2

All-Cause Mortality
Treatment Without Paliferim Treatment With Palifermin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Without Paliferim Treatment With Palifermin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   1/5 (20.00%) 
General disorders     
PAIN - OTHER * 1  0/3 (0.00%)  1/5 (20.00%) 
Infections and infestations     
INFECTION - OTHER * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) * 1  0/3 (0.00%)  1/5 (20.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Without Paliferim Treatment With Palifermin
Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders     
BLOOD/BONE MARROW - OTHER * 1  1/3 (33.33%)  0/5 (0.00%) 
COAGULATION - OTHER * 1  1/3 (33.33%)  0/5 (0.00%) 
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE * 1  1/3 (33.33%)  4/5 (80.00%) 
LYMPHATICS - OTHER * 1  1/3 (33.33%)  0/5 (0.00%) 
THROMBOTIC MICROANGIOPATHY (E.G., THROMBOTIC THROMBOCYTOPENIC PURPURA [TTP] OR HEMOLYTIC UREMIC SYND * 1  0/3 (0.00%)  1/5 (20.00%) 
Cardiac disorders     
CARDIAC GENERAL - OTHER * 1  0/3 (0.00%)  1/5 (20.00%) 
LEFT VENTRICULAR DIASTOLIC DYSFUNCTION * 1  0/3 (0.00%)  1/5 (20.00%) 
PERICARDIAL EFFUSION (NON-MALIGNANT) * 1  1/3 (33.33%)  1/5 (20.00%) 
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - ATRIAL FIBRILLATION * 1  1/3 (33.33%)  0/5 (0.00%) 
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA * 1  3/3 (100.00%)  4/5 (80.00%) 
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA * 1  0/3 (0.00%)  1/5 (20.00%) 
Eye disorders     
OCULAR/VISUAL - OTHER * 1  1/3 (33.33%)  0/5 (0.00%) 
VISION-BLURRED VISION * 1  1/3 (33.33%)  1/5 (20.00%) 
Gastrointestinal disorders     
ASCITES (NON-MALIGNANT) * 1  1/3 (33.33%)  0/5 (0.00%) 
CONSTIPATION * 1  1/3 (33.33%)  2/5 (40.00%) 
DIARRHEA * 1  3/3 (100.00%)  5/5 (100.00%) 
DISTENSION/BLOATING, ABDOMINAL * 1  1/3 (33.33%)  0/5 (0.00%) 
HEARTBURN/DYSPEPSIA * 1  2/3 (66.67%)  0/5 (0.00%) 
ILEUS, GI (FUNCTIONAL OBSTRUCTION OF BOWEL, I.E., NEUROCONSTIPATION) * 1  0/3 (0.00%)  2/5 (40.00%) 
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY * 1  1/3 (33.33%)  2/5 (40.00%) 
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - LARGE BOWEL * 1  0/3 (0.00%)  1/5 (20.00%) 
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY * 1  2/3 (66.67%)  2/5 (40.00%) 
NAUSEA * 1  3/3 (100.00%)  5/5 (100.00%) 
PAIN - ABDOMEN NOS * 1  2/3 (66.67%)  3/5 (60.00%) 
PAIN - ORAL CAVITY * 1  0/3 (0.00%)  1/5 (20.00%) 
PAIN - RECTUM * 1  1/3 (33.33%)  0/5 (0.00%) 
VOMITING * 1  3/3 (100.00%)  5/5 (100.00%) 
General disorders     
CONSTITUTIONAL SYMPTOMS - OTHER * 1  0/3 (0.00%)  1/5 (20.00%) 
EDEMA: LIMB * 1  3/3 (100.00%)  5/5 (100.00%) 
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) * 1  3/3 (100.00%)  5/5 (100.00%) 
PAIN - OTHER * 1  1/3 (33.33%)  2/5 (40.00%) 
PAIN - PAIN NOS * 1  0/3 (0.00%)  1/5 (20.00%) 
RIGORS/CHILLS * 1  0/3 (0.00%)  2/5 (40.00%) 
Hepatobiliary disorders     
BILIRUBIN (HYPERBILIRUBINEMIA) * 1  3/3 (100.00%)  4/5 (80.00%) 
CHOLECYSTITIS * 1  0/3 (0.00%)  1/5 (20.00%) 
HEPATOBILIARY/PANCREAS - OTHER * 1  1/3 (33.33%)  0/5 (0.00%) 
Infections and infestations     
COLITIS, INFECTIOUS (E.G., CLOSTRIDIUM DIFFICILE) * 1  1/3 (33.33%)  2/5 (40.00%) 
INFECTION - OTHER * 1  3/3 (100.00%)  3/5 (60.00%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY) * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLOOD * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ORAL CAVITY-GUMS (GINGIVITIS) * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - VAGINA * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH UNKNOWN ANC - BLADDER (URINARY) * 1  0/3 (0.00%)  3/5 (60.00%) 
INFECTION WITH UNKNOWN ANC - BLOOD * 1  1/3 (33.33%)  3/5 (60.00%) 
INFECTION WITH UNKNOWN ANC - CATHETER-RELATED * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH UNKNOWN ANC - COLON * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH UNKNOWN ANC - LIP/PERIORAL * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS) * 1  0/3 (0.00%)  1/5 (20.00%) 
INFECTION WITH UNKNOWN ANC - SINUS * 1  0/3 (0.00%)  2/5 (40.00%) 
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS * 1  0/3 (0.00%)  3/5 (60.00%) 
Injury, poisoning and procedural complications     
RASH: DERMATITIS ASSOCIATED WITH RADIATION - RADIATION * 1  0/3 (0.00%)  1/5 (20.00%) 
Investigations     
ALKALINE PHOSPHATASE * 1  3/3 (100.00%)  4/5 (80.00%) 
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) * 1  3/3 (100.00%)  5/5 (100.00%) 
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) * 1  3/3 (100.00%)  4/5 (80.00%) 
CREATININE * 1  2/3 (66.67%)  4/5 (80.00%) 
Metabolism and nutrition disorders     
DEHYDRATION * 1  0/3 (0.00%)  4/5 (80.00%) 
Musculoskeletal and connective tissue disorders     
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER * 1  1/3 (33.33%)  0/5 (0.00%) 
PAIN - BACK * 1  2/3 (66.67%)  2/5 (40.00%) 
PAIN - BONE * 1  0/3 (0.00%)  1/5 (20.00%) 
PAIN - EXTREMITY-LIMB * 1  1/3 (33.33%)  0/5 (0.00%) 
PAIN - JOINT * 1  0/3 (0.00%)  1/5 (20.00%) 
PAIN - MUSCLE * 1  0/3 (0.00%)  2/5 (40.00%) 
Nervous system disorders     
DIZZINESS * 1  1/3 (33.33%)  1/5 (20.00%) 
ENCEPHALOPATHY * 1  1/3 (33.33%)  0/5 (0.00%) 
EXTRAPYRAMIDAL/INVOLUNTARY MOVEMENT/RESTLESSNESS * 1  1/3 (33.33%)  0/5 (0.00%) 
MEMORY IMPAIRMENT * 1  0/3 (0.00%)  1/5 (20.00%) 
NEUROPATHY: SENSORY * 1  1/3 (33.33%)  3/5 (60.00%) 
PAIN - HEAD/HEADACHE * 1  2/3 (66.67%)  1/5 (20.00%) 
Psychiatric disorders     
CONFUSION * 1  0/3 (0.00%)  1/5 (20.00%) 
INSOMNIA * 1  0/3 (0.00%)  1/5 (20.00%) 
MENTAL STATUS * 1  0/3 (0.00%)  2/5 (40.00%) 
MOOD ALTERATION - DEPRESSION * 1  0/3 (0.00%)  1/5 (20.00%) 
Renal and urinary disorders     
HEMORRHAGE, GU - BLADDER * 1  0/3 (0.00%)  1/5 (20.00%) 
HEMORRHAGE, GU - URINARY NOS * 1  1/3 (33.33%)  0/5 (0.00%) 
RENAL FAILURE * 1  1/3 (33.33%)  0/5 (0.00%) 
RENAL/GENITOURINARY - OTHER * 1  1/3 (33.33%)  2/5 (40.00%) 
Reproductive system and breast disorders     
ERECTILE DYSFUNCTION * 1  0/3 (0.00%)  1/5 (20.00%) 
HEMORRHAGE, GU - VAGINA * 1  0/3 (0.00%)  1/5 (20.00%) 
IRREGULAR MENSES (CHANGE FROM BASELINE) * 1  0/3 (0.00%)  1/5 (20.00%) 
PAIN - PERINEUM * 1  0/3 (0.00%)  1/5 (20.00%) 
Respiratory, thoracic and mediastinal disorders     
ADULT RESPIRATORY DISTRESS SYNDROME (ARDS) * 1  1/3 (33.33%)  0/5 (0.00%) 
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) * 1  0/3 (0.00%)  1/5 (20.00%) 
COUGH * 1  1/3 (33.33%)  3/5 (60.00%) 
DYSPNEA (SHORTNESS OF BREATH) * 1  3/3 (100.00%)  4/5 (80.00%) 
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE * 1  1/3 (33.33%)  1/5 (20.00%) 
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS * 1  0/3 (0.00%)  1/5 (20.00%) 
HYPOXIA * 1  2/3 (66.67%)  3/5 (60.00%) 
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - PHARYNX * 1  0/3 (0.00%)  1/5 (20.00%) 
NASAL CAVITY/PARANASAL SINUS REACTIONS * 1  0/3 (0.00%)  1/5 (20.00%) 
PAIN - THROAT/PHARYNX/LARYNX * 1  0/3 (0.00%)  1/5 (20.00%) 
PLEURAL EFFUSION (NON-MALIGNANT) * 1  2/3 (66.67%)  1/5 (20.00%) 
PULMONARY/UPPER RESPIRATORY - OTHER * 1  0/3 (0.00%)  2/5 (40.00%) 
Skin and subcutaneous tissue disorders     
DERMATOLOGY/SKIN - OTHER * 1  1/3 (33.33%)  0/5 (0.00%) 
HYPERPIGMENTATION * 1  0/3 (0.00%)  1/5 (20.00%) 
PRURITUS/ITCHING * 1  0/3 (0.00%)  2/5 (40.00%) 
RASH/DESQUAMATION * 1  2/3 (66.67%)  2/5 (40.00%) 
Vascular disorders     
HYPERTENSION * 1  0/3 (0.00%)  1/5 (20.00%) 
HYPOTENSION * 1  1/3 (33.33%)  1/5 (20.00%) 
THROMBOSIS/THROMBUS/EMBOLISM * 1  1/3 (33.33%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Sherif Farag
Organization: IndianaU
Phone: 317-278-0460
Responsible Party: Sherif S. Farag, Indiana University
ClinicalTrials.gov Identifier: NCT00593554     History of Changes
Other Study ID Numbers: 0704-19 IUCRO-0184
First Submitted: January 4, 2008
First Posted: January 15, 2008
Results First Submitted: March 12, 2018
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018