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Trial record 16 of 83 for:    "Adult Acute Lymphocytic Leukemia" | "Antineoplastic Agents, Hormonal"

Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease

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ClinicalTrials.gov Identifier: NCT00929695
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : October 9, 2014
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Marco Mielcarek, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Graft Versus Host Disease
Recurrent Adult Acute Lymphoblastic Leukemia
Interventions Drug: prednisone
Drug: methylprednisolone
Other: questionnaire administration
Enrollment 164
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone. Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Period Title: Overall Study
Started 81 83
Completed 73 77
Not Completed 8 6
Reason Not Completed
Death             2             1
Withdrawal by Subject             0             2
discharge home             4             3
incorrect stratification             2             0
Arm/Group Title Group A (Low-dose) Group B (Standard-dose) Total
Hide Arm/Group Description Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone. Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone. Total of all reporting groups
Overall Number of Baseline Participants 73 77 150
Hide Baseline Analysis Population Description
From a total enrollment of 164 patients, 150 were analyzed for the primary endpoint. Excluded from the analysis were 14 patients: 12 withdrew, died or were discharged from the Center early and did not have 42 days of cumulative prednisone dosing and 2 were stratified incorrectly.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 77 participants 150 participants
<=18 years
8
  11.0%
14
  18.2%
22
  14.7%
Between 18 and 65 years
59
  80.8%
56
  72.7%
115
  76.7%
>=65 years
6
   8.2%
7
   9.1%
13
   8.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 77 participants 150 participants
Female
31
  42.5%
26
  33.8%
57
  38.0%
Male
42
  57.5%
51
  66.2%
93
  62.0%
1.Primary Outcome
Title Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
Hide Description The total cumulative dose of prednisone (milligrams/kilogram) was calculated starting from the start of therapy through study day 42.
Time Frame At day 42 after initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
From a total enrollment of 164 patients, the cumulative dose of prednisone at day 42 of treatment was available in 152 patients. The primary outcome was not measured in 12 patients due to withdrawal from study (2), discharge from Center before day 42 of treatment (10). Analysis was not completed in two patients due to an error in stratification.
Arm/Group Title Grade IIa GVHD; 0.5 mg/kg/d Prednisone Grade IIa GVHD; 1.0 mg/kg/d Prednisone Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Hide Arm/Group Description:
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
Overall Number of Participants Analyzed 44 47 29 30
Mean (Standard Deviation)
Unit of Measure: milligrams per kilogram
22.2  (13.7) 27.1  (12.7) 38.4  (14.1) 41.3  (12.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Grade IIa GVHD; 0.5 mg/kg/d Prednisone, Grade IIa GVHD; 1.0 mg/kg/d Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone, Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Prednisone-associated Toxicity as Assessed by Hyperglycemia
Hide Description Impact on blood glucose (BG) control will be assessed by comparing average BG and BG-variability between patients given standard-dose and low-dose prednisone.
Time Frame Baseline and then through 42 days after starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Overall Number of Participants Analyzed 79 83
Mean (Standard Error)
Unit of Measure: mg/dL
140  (7.4) 142  (12.9)
3.Secondary Outcome
Title Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral)
Hide Description The total number of invasive infections (bacterial, fungal and viral) occurring in patients in each group were collected.
Time Frame Baseline and through 100 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Measure Type: Number
Unit of Measure: percentage of participants
52 53
4.Secondary Outcome
Title Prednisone-associated Toxicity as Assessed by Myopathy
Hide Description Assessed by mean change from baseline to day 42 using Manual Muscle Testing measure. The degree of resistance against pressure applied by tester was measured on a 5-point scale. A score of 5 indicates the patient can hold the position against maximum to strong resistance. A score of 0 indicates the patient has no resistance against pressure. Testing included upper and lower extremities: shoulder (deltoid at 90 degrees), and hip and knee in a sitting position.
Time Frame Baseline and then weekly until 42 days after starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Overall Number of Participants Analyzed 79 83
Mean (Full Range)
Unit of Measure: units on a scale
-0.18
(-1.5 to 1.5)
-0.18
(-1.5 to 1.5)
5.Secondary Outcome
Title Prednisone-associated Toxicity as Assessed by Hypertension
Hide Description The number of different anti-hypertensive medications administered to control hypertension were collected. The mean change in the number of medications from baseline to day 42 was measured.
Time Frame Baseline and then through 42 days after starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Mean (Full Range)
Unit of Measure: medications
-0.29
(-0.50 to 0.50)
-0.24
(-0.50 to 0.50)
6.Secondary Outcome
Title Prednisone-associated Toxicity as Assessed by Quality of Life
Hide Description Patients completed the MD Anderson Symptom Inventory (MDASI), which is a quality of life questionnaire validated for oncology/transplant patients. On a 1-10 point scale, patients scored the degree of severity of symptoms or the degree of interference in feelings or function due to symptoms at baseline or in the previous week. A score of 1 indicates symptom is not present or does not interfere with feelings or function. A score of 10 indicates the symptom is as bad as you can imagine or interferes completely with feelings or function. The mean change in score from baseline to day 42 was measured.
Time Frame Baseline and then every other week until 42 days after starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Mean (Full Range)
Unit of Measure: units on a scale
-2.3
(-5 to 5)
-1.9
(-5 to 5)
7.Secondary Outcome
Title Non-relapse Mortality
Hide Description Non-relapse mortality (NRM) is defined as death due to any cause in the absence of documented relapse/progression.
Time Frame At 12 months after the start of prednisone therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Measure Type: Number
Unit of Measure: percentage of participants
15 16
8.Secondary Outcome
Title Recurrent or Progressive Malignancy
Hide Description Percentage of relapse estimated by cumulative incidence methods
Time Frame At 12 months after the start of prednisone therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Measure Type: Number
Unit of Measure: percentage of participants
21 21
9.Secondary Outcome
Title Progression to Grade III-IV Acute GVHD
Hide Description Diagnosed and graded according to standard established criteria. Measure is percent of patients with baseline scores of IIa (Group A) or IIb (Group B) who progressed to more severe GVHD (Grade III/IV). Percentage estimated by cumulative incidence methods.
Time Frame At approximately 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Measure Type: Number
Unit of Measure: percentage of participants
6 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Low-dose), Group B (Standard-dose)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.14 to 1.33
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Secondary Therapy for Acute GVHD Beyond Prednisone
Hide Description This includes any intervention intended to control acute GVHD through an immunosuppressive effect from oral or parenteral administration of any systemic medication not given previously. This does not include topical therapy, an increase in the dose of glucocorticoids or the resumption of treatment after previous discontinuation or any increase in the dose of immunosuppressive medication previously administered for GVHD prophylaxis, or reinstatement of GVHD prophylaxis previously discontinued. A change in treatment from cyclosporine to tacrolimus or vice versa because of drug toxicity is not considered secondary therapy, but any change made because of uncontrolled GVHD is considered secondary therapy. Percentage is estimated by cumulative incidence methods.
Time Frame At approximately 100 days after transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Measure Type: Number
Unit of Measure: percentage of participants
23 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Low-dose), Group B (Standard-dose)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
0.12 to 0.74
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Chronic Extensive GVHD
Hide Description Percentage of patients with chronic extensive GVHD, estimated by cumulative incidence methods
Time Frame At 12 months after the start of prednisone therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Measure Type: Number
Unit of Measure: percentage of participants
47 54
12.Secondary Outcome
Title Overall Survival
Hide Description Percentage of patients surviving as estimated by Kaplan-Meier.
Time Frame At 12 months after the start of prednisone therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A (Low-dose) Group B (Standard-dose)
Hide Arm/Group Description:
Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
Overall Number of Participants Analyzed 79 83
Measure Type: Number
Unit of Measure: percentage of participants
77 77
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A (Low-dose), Group B (Standard-dose)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.6 to 1.74
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Other (Non-serious) adverse events were not collected, only those events that could be caused by prednisone "under-treatment" were monitored. These include 1) the progression to grade III/IV acute GVHD, 2) the need for secondary systemic GVHD treatment, and 3) non-relapse mortality. These events are reported as secondary Outcome Measures.
 
Arm/Group Title Arm I (Low-dose) Arm II (Standard-dose)
Hide Arm/Group Description

Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.

prednisone: immunosuppressive drug

methylprednisolone: immunosuppressive drug

questionnaire administration: Ancillary studies

Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.

prednisone: immunosuppressive drug

methylprednisolone: immunosuppressive drug

questionnaire administration: Ancillary studies

All-Cause Mortality
Arm I (Low-dose) Arm II (Standard-dose)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Low-dose) Arm II (Standard-dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/81 (46.91%)      30/83 (36.14%)    
Blood and lymphatic system disorders     
platelet infusion reaction  0/81 (0.00%)  0 1/83 (1.20%)  1
relapse of hematological disease  1/81 (1.23%)  1 4/83 (4.82%)  4
hematopoietic graft failure  0/81 (0.00%)  0 1/83 (1.20%)  1
Cardiac disorders     
peripheral edema  0/81 (0.00%)  0 1/83 (1.20%)  1
palpitations  1/81 (1.23%)  1 0/83 (0.00%)  0
orthostatic hypotension  1/81 (1.23%)  1 0/83 (0.00%)  0
chest pain  1/81 (1.23%)  3 1/83 (1.20%)  1
congestive heart failure  1/81 (1.23%)  1 0/83 (0.00%)  0
atrial fibrillation  0/81 (0.00%)  0 1/83 (1.20%)  1
hypertension  0/81 (0.00%)  0 1/83 (1.20%)  1
Gastrointestinal disorders     
abdominal pain  1/81 (1.23%)  1 1/83 (1.20%)  1
gastroesophageal relux disease  1/81 (1.23%)  1 0/83 (0.00%)  0
splenomagaly  0/81 (0.00%)  0 1/83 (1.20%)  1
nausea/vomiting  1/81 (1.23%)  1 1/83 (1.20%)  1
colonic pneumatosis  1/81 (1.23%)  1 0/83 (0.00%)  0
General disorders     
trauma/fall  1/81 (1.23%)  1 0/83 (0.00%)  0
Hepatobiliary disorders     
elevated liver function tests  1/81 (1.23%)  1 0/83 (0.00%)  0
Immune system disorders     
graft versus host disease  8/81 (9.88%)  9 0/83 (0.00%)  0
Infections and infestations     
fever/infection  13/81 (16.05%)  14 11/83 (13.25%)  13
Musculoskeletal and connective tissue disorders     
temporomandibular joint disorder  1/81 (1.23%)  1 0/83 (0.00%)  0
leg pain  0/81 (0.00%)  0 1/83 (1.20%)  1
weakness  1/81 (1.23%)  1 0/83 (0.00%)  0
Nervous system disorders     
lethargy  0/81 (0.00%)  0 1/83 (1.20%)  1
mental status changes  1/81 (1.23%)  1 2/83 (2.41%)  2
Respiratory, thoracic and mediastinal disorders     
adult respiratory distress syndrome  0/81 (0.00%)  0 1/83 (1.20%)  1
hypoxemia  1/81 (1.23%)  1 0/83 (0.00%)  0
diffuse alveolar hemorrhage  0/81 (0.00%)  0 1/83 (1.20%)  1
Skin and subcutaneous tissue disorders     
parotitis  1/81 (1.23%)  1 0/83 (0.00%)  0
Social circumstances     
suicide  1/81 (1.23%)  1 0/83 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Low-dose) Arm II (Standard-dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marco Mielcarek
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-2827
EMail: mmielcar@fhcrc.org
Layout table for additonal information
Responsible Party: Marco Mielcarek, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00929695     History of Changes
Other Study ID Numbers: 2327.00
NCI-2010-00323 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P01CA018029 ( U.S. NIH Grant/Contract )
First Submitted: June 25, 2009
First Posted: June 29, 2009
Results First Submitted: September 19, 2014
Results First Posted: October 9, 2014
Last Update Posted: August 21, 2017