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Trial record 25 of 179 for:    "Lymphomatoid Granulomatosis"

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic 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: NCT01273766
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : November 27, 2013
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Acute Undifferentiated Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
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)
Adult Grade III Lymphomatoid Granulomatosis
Adult Langerhans Cell Histiocytosis
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Contiguous Stage II Adult Burkitt Lymphoma
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Contiguous Stage II Adult Lymphoblastic Lymphoma
Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Contiguous Stage II Mantle Cell Lymphoma
Contiguous Stage II Marginal Zone Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
Cutaneous B-cell Non-Hodgkin Lymphoma
de Novo Myelodysplastic Syndromes
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Intraocular Lymphoma
Mast Cell Leukemia
Myelodysplastic Syndrome With Isolated Del(5q)
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Myeloid/NK-cell Acute Leukemia
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Burkitt Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma
Noncontiguous Stage II Adult Lymphoblastic Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Noncontiguous Stage II Marginal Zone Lymphoma
Noncontiguous Stage II Small Lymphocytic Lymphoma
Noncutaneous Extranodal Lymphoma
Peripheral T-cell Lymphoma
Previously Treated Myelodysplastic Syndromes
Primary Myelofibrosis
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Recurrent Small Lymphocytic Lymphoma
Refractory Anemia
Refractory Multiple Myeloma
Secondary Acute Myeloid Leukemia
Secondary Myelofibrosis
Small Intestine Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Adult Burkitt Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Stage I Adult Diffuse Mixed Cell Lymphoma
Stage I Adult Diffuse Small Cleaved Cell Lymphoma
Stage I Adult Hodgkin Lymphoma
Stage I Adult Immunoblastic Large Cell Lymphoma
Stage I Adult Lymphoblastic Lymphoma
Stage I Adult T-cell Leukemia/Lymphoma
Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
Stage I Grade 1 Follicular Lymphoma
Stage I Grade 2 Follicular Lymphoma
Stage I Grade 3 Follicular Lymphoma
Stage I Mantle Cell Lymphoma
Stage I Marginal Zone Lymphoma
Stage I Multiple Myeloma
Stage I Mycosis Fungoides/Sezary Syndrome
Stage I Small Lymphocytic Lymphoma
Stage II Adult Hodgkin Lymphoma
Stage II Adult T-cell Leukemia/Lymphoma
Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
Stage II Multiple Myeloma
Stage II Mycosis Fungoides/Sezary Syndrome
Stage III Adult Burkitt Lymphoma
Stage III Adult Diffuse Large Cell Lymphoma
Stage III Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Diffuse Small Cleaved Cell Lymphoma
Stage III Adult Hodgkin Lymphoma
Stage III Adult Immunoblastic Large Cell Lymphoma
Stage III Adult Lymphoblastic Lymphoma
Stage III Adult T-cell Leukemia/Lymphoma
Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage III Mantle Cell Lymphoma
Stage III Marginal Zone Lymphoma
Stage III Multiple Myeloma
Stage III Mycosis Fungoides/Sezary Syndrome
Stage III Small Lymphocytic Lymphoma
Stage IV Adult Burkitt Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Mixed Cell Lymphoma
Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
Stage IV Adult Hodgkin Lymphoma
Stage IV Adult Immunoblastic Large Cell Lymphoma
Stage IV Adult Lymphoblastic Lymphoma
Stage IV Adult T-cell Leukemia/Lymphoma
Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Stage IV Mantle Cell Lymphoma
Stage IV Marginal Zone Lymphoma
Stage IV Mycosis Fungoides/Sezary Syndrome
Stage IV Small Lymphocytic Lymphoma
Testicular Lymphoma
Untreated Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Myeloid Leukemia
Waldenstrom Macroglobulinemia
Interventions Drug: deferasirox
Other: laboratory biomarker analysis
Other: enzyme-linked immunosorbent assay
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I Control Arm Correlative
Hide Arm/Group Description

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.

deferasirox : Given orally

laboratory biomarker analysis : Correlative studies

enzyme-linked immunosorbent assay : Correlative studies

blood tested on healthy patients treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
Period Title: Overall Study
Started 4 7 5
Completed 4 7 5
Not Completed 0 0 0
Arm/Group Title Arm I Control Arm Correlative Total
Hide Arm/Group Description

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.

deferasirox : Given orally

laboratory biomarker analysis : Correlative studies

enzyme-linked immunosorbent assay : Correlative studies

blood tested on healthy patients treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis Total of all reporting groups
Overall Number of Baseline Participants 4 7 5 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 5 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
7
 100.0%
4
  80.0%
14
  87.5%
>=65 years
1
  25.0%
0
   0.0%
1
  20.0%
2
  12.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 7 participants 5 participants 16 participants
53.1  (12.9) 40.1  (7.0) 55.0  (17.6) 48.0  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 5 participants 16 participants
Female
2
  50.0%
6
  85.7%
1
  20.0%
9
  56.3%
Male
2
  50.0%
1
  14.3%
4
  80.0%
7
  43.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 7 participants 5 participants 16 participants
4 7 5 16
1.Primary Outcome
Title Changes in Mean Neutrophil Values (as Measured by Lab) for Arm 1 (Other Arms Were Used for Calibration Only)
Hide Description Changes in Neutrophils between baseline and mean neutrophils values during treatment (measured after each dose)
Time Frame Baseline, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.

deferasirox : Given orally

laboratory biomarker analysis : Correlative studies

enzyme-linked immunosorbent assay : Correlative studies

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: 10^9 Neutrophils per Liter
7.8  (138.4)
2.Secondary Outcome
Title Need for Hospitalization, Ventilator Support, Exchange Transfusion/Apheresis or Treatment With Antifungals or Antibiotics
Hide Description Records will be assessed at baseline and prospectively while on study.
Time Frame Baseline, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number analyzed in rows differs from overall because data was not collected on all participants.
Arm/Group Title Arm I Correlative
Hide Arm/Group Description:

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.

deferasirox : Given orally

laboratory biomarker analysis : Correlative studies

enzyme-linked immunosorbent assay : Correlative studies

treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline : Hospitalization Number Analyzed 2 participants 5 participants
2
 100.0%
5
 100.0%
Baseline : Ventilator Number Analyzed 2 participants 5 participants
0
   0.0%
1
  20.0%
Baseline : Transfusion Number Analyzed 2 participants 5 participants
0
   0.0%
0
   0.0%
Baseline : Antibiotics Number Analyzed 2 participants 5 participants
0
   0.0%
5
 100.0%
1 Month : Hospitalization Number Analyzed 3 participants 3 participants
1
  33.3%
1
  33.3%
1 Month : Ventilator Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
1 Month : Transfusion Number Analyzed 3 participants 3 participants
0
   0.0%
1
  33.3%
1 Month : Antibiotics Number Analyzed 3 participants 3 participants
1
  33.3%
1
  33.3%
2 Month : Hospitalization Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
2 Month : Ventilator Number Analyzed 4 participants 3 participants
0
   0.0%
0
   0.0%
2 Month : Transfusion Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
2 Month : Antibiotics Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
3 Month : Hospitalization Number Analyzed 4 participants 4 participants
0
   0.0%
1
  25.0%
3 Month : Ventilator Number Analyzed 4 participants 4 participants
0
   0.0%
0
   0.0%
3 Month : Transfusion Number Analyzed 4 participants 4 participants
0
   0.0%
1
  25.0%
3 Month : Antibiotics Number Analyzed 4 participants 4 participants
0
   0.0%
0
   0.0%
4 Month : Hospitalization Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
4 Month : Ventilator Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
4 Month : Transfusion Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
4 Month : Antibiotics Number Analyzed 4 participants 3 participants
1
  25.0%
1
  33.3%
5 Month : Hospitalization Number Analyzed 3 participants 2 participants
0
   0.0%
2
 100.0%
5 Month : Ventilator Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
5 Month : Transfusion Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
5 Month : Antibiotics Number Analyzed 3 participants 2 participants
0
   0.0%
1
  50.0%
6 Month : Hospitalization Number Analyzed 4 participants 2 participants
3
  75.0%
0
   0.0%
6 Month : Ventilator Number Analyzed 4 participants 2 participants
0
   0.0%
0
   0.0%
6 Month : Transfusion Number Analyzed 4 participants 2 participants
0
   0.0%
0
   0.0%
6 Month : Antibiotics Number Analyzed 4 participants 2 participants
1
  25.0%
0
   0.0%
3.Secondary Outcome
Title Cumulative Incidence of Documented Bacterial, Fungal, and Viral Infections
Hide Description Records will be assessed at baseline and prospectively while on study.
Time Frame Baseline, up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Correlative
Hide Arm/Group Description:

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.

deferasirox : Given orally

laboratory biomarker analysis : Correlative studies

enzyme-linked immunosorbent assay : Correlative studies

treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
5
 100.0%
Time Frame 6 months
Adverse Event Reporting Description only patients on Arm I (recieving drug on protocol) were tracked for toxicities
 
Arm/Group Title Arm I Control Arm Correlative
Hide Arm/Group Description

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.

deferasirox : Given orally

laboratory biomarker analysis : Correlative studies

enzyme-linked immunosorbent assay : Correlative studies

blood tested on healthy patients treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
All-Cause Mortality
Arm I Control Arm Correlative
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Control Arm Correlative
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      0/0      0/0    
General disorders       
Fatigue   2/4 (50.00%)  3 0/0  0 0/0  0
Heartburn/dyspepsia   1/4 (25.00%)  1 0/0  0 0/0  0
Confusion   1/4 (25.00%)  1 0/0  0 0/0  0
"Distension bloating, abdominal"   1/4 (25.00%)  1 0/0  0 0/0  0
Infections and infestations       
Infection Bladder   1/4 (25.00%)  2 0/0  0 0/0  0
Cystitis   1/4 (25.00%)  1 0/0  0 0/0  0
Lung infection   1/4 (25.00%)  1 0/0  0 0/0  0
Infection Sinus   1/4 (25.00%)  1 0/0  0 0/0  0
Injury, poisoning and procedural complications       
Infection with normal ANC or Grade 1 or 2 neutrophils: Nose   1/4 (25.00%)  2 0/0  0 0/0  0
Investigations       
hyperglycemia   2/4 (50.00%)  6 0/0  0 0/0  0
hyponatremia   1/4 (25.00%)  1 0/0  0 0/0  0
hypokalemia   1/4 (25.00%)  1 0/0  0 0/0  0
serum glutamic pyruvic transaminase   1/4 (25.00%)  1 0/0  0 0/0  0
Lipase   1/4 (25.00%)  1 0/0  0 0/0  0
Lymphopenia   1/4 (25.00%)  2 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea   2/4 (50.00%)  2 0/0  0 0/0  0
Vascular disorders       
Thrombosis/thrombus/embolism   1/4 (25.00%)  1 0/0  0 0/0  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I Control Arm Correlative
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      0/0      0/0    
Eye disorders       
Ocular/Visual - Other   1/4 (25.00%)  1 0/0  0 0/0  0
Dry eye syndrome   1/4 (25.00%)  1 0/0  0 0/0  0
blurred vision   1/4 (25.00%)  1 0/0  0 0/0  0
Gastrointestinal disorders       
Nausea   1/4 (25.00%)  2 0/0  0 0/0  0
Vomiting   1/4 (25.00%)  3 0/0  0 0/0  0
Constipation   2/4 (50.00%)  4 0/0  0 0/0  0
General disorders       
Anorexia   2/4 (50.00%)  2 0/0  0 0/0  0
Gastrointestinal - Other   1/4 (25.00%)  1 0/0  0 0/0  0
Taste alteration   1/4 (25.00%)  5 0/0  0 0/0  0
Insomnia   1/4 (25.00%)  1 0/0  0 0/0  0
Fatigue   1/4 (25.00%)  2 0/0  0 0/0  0
Weight loss   1/4 (25.00%)  1 0/0  0 0/0  0
Pain: Head/headache   1/4 (25.00%)  1 0/0  0 0/0  0
Urinary frequency/urgency   1/4 (25.00%)  1 0/0  0 0/0  0
Renal/Genitourinary - Other   1/4 (25.00%)  1 0/0  0 0/0  0
Intra-operative Injury   1/4 (25.00%)  1 0/0  0 0/0  0
Musculoskeletal Soft Tissue - Other   1/4 (25.00%)  1 0/0  0 0/0  0
Dry mouth   3/4 (75.00%)  3 0/0  0 0/0  0
Dehydration   2/4 (50.00%)  3 0/0  0 0/0  0
Pruritus/itching   1/4 (25.00%)  2 0/0  0 0/0  0
Pain: Abdomen   1/4 (25.00%)  1 0/0  0 0/0  0
Ataxia   1/4 (25.00%)  1 0/0  0 0/0  0
Obstruction Bladder   1/4 (25.00%)  1 0/0  0 0/0  0
Pain Bladder   1/4 (25.00%)  1 0/0  0 0/0  0
Urine color change   1/4 (25.00%)  1 0/0  0 0/0  0
Anal Incontinence   1/4 (25.00%)  1 0/0  0 0/0  0
Memory impairment   1/4 (25.00%)  1 0/0  0 0/0  0
Pain: Muscle   1/4 (25.00%)  1 0/0  0 0/0  0
Pain Oral cavity   1/4 (25.00%)  1 0/0  0 0/0  0
Pain: Extremity-limb   1/4 (25.00%)  1 0/0  0 0/0  0
Hyperpigmentation   1/4 (25.00%)  5 0/0  0 0/0  0
Infections and infestations       
Lung infection   2/4 (50.00%)  3 0/0  0 0/0  0
Mucositis/stomatitis Oral cavity   2/4 (50.00%)  2 0/0  0 0/0  0
Mucositis/stomatitis Oral cavity   3/4 (75.00%)  11 0/0  0 0/0  0
Infection Lip perioral   1/4 (25.00%)  1 0/0  0 0/0  0
Blood Infection with high grade neutropenia   1/4 (25.00%)  2 0/0  0 0/0  0
Investigations       
Low WBC   1/4 (25.00%)  1 0/0  0 0/0  0
low Platelets   3/4 (75.00%)  9 0/0  0 0/0  0
Low Hemoglobin   4/4 (100.00%)  15 0/0  0 0/0  0
Alkaline phosphatase   3/4 (75.00%)  10 0/0  0 0/0  0
Creatinine   2/4 (50.00%)  7 0/0  0 0/0  0
Proteinuria   2/4 (50.00%)  2 0/0  0 0/0  0
hyperglycemia   4/4 (100.00%)  15 0/0  0 0/0  0
hypoglycemia   1/4 (25.00%)  1 0/0  0 0/0  0
hypocalcemia   4/4 (100.00%)  4 0/0  0 0/0  0
hypomagnesemia   3/4 (75.00%)  3 0/0  0 0/0  0
hyponatremia   3/4 (75.00%)  7 0/0  0 0/0  0
hypokalemia   1/4 (25.00%)  3 0/0  0 0/0  0
hypoalbuminemia   4/4 (100.00%)  6 0/0  0 0/0  0
hyperbilirubinemia   1/4 (25.00%)  1 0/0  0 0/0  0
serum glutamic pyruvic transaminase   2/4 (50.00%)  10 0/0  0 0/0  0
serum glutamic oxaloacetic transaminase   1/4 (25.00%)  6 0/0  0 0/0  0
hypermagnesemia   2/4 (50.00%)  4 0/0  0 0/0  0
hyperkalemia   1/4 (25.00%)  2 0/0  0 0/0  0
Amylase   1/4 (25.00%)  2 0/0  0 0/0  0
gamma-Glutamyl transpeptidase   1/4 (25.00%)  1 0/0  0 0/0  0
Glomerular filtration rate   2/4 (50.00%)  4 0/0  0 0/0  0
Lipase   1/4 (25.00%)  1 0/0  0 0/0  0
Lymphopenia   2/4 (50.00%)  4 0/0  0 0/0  0
Nervous system disorders       
Tremor   1/4 (25.00%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea   1/4 (25.00%)  1 0/0  0 0/0  0
Cough   2/4 (50.00%)  3 0/0  0 0/0  0
Bronchospasm wheezing   1/4 (25.00%)  1 0/0  0 0/0  0
Skin and subcutaneous tissue disorders       
Dermatology/Skin   1/4 (25.00%)  1 0/0  0 0/0  0
Rash/desquamation   2/4 (50.00%)  5 0/0  0 0/0  0
Allergic rhinitis   1/4 (25.00%)  1 0/0  0 0/0  0
Vascular disorders       
Hemorrhage GU: Urinary   1/4 (25.00%)  2 0/0  0 0/0  0
Thrombosis/embolism (vascular access-related)   1/4 (25.00%)  1 0/0  0 0/0  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Mary Ann Knovich
Organization: Comprehensive Cancer Center of Wake Forest University
Phone: 336-716-7973
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01273766     History of Changes
Other Study ID Numbers: IRB00015287
NCI-2010-02228 ( Other Grant/Funding Number: NCI )
CCCWFU 97710 ( Other Identifier: Wake Forest University Health Sciences )
First Submitted: January 7, 2011
First Posted: January 10, 2011
Results First Submitted: June 20, 2013
Results First Posted: November 27, 2013
Last Update Posted: September 7, 2018