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Trial record 77 of 325 for:    "Acute Lymphocytic Leukemia" | "Methotrexate"

S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00109837
Recruitment Status : Completed
First Posted : May 4, 2005
Results First Posted : August 23, 2012
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Biological: filgrastim
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin
Drug: dexamethasone
Drug: doxorubicin
Drug: leucovorin
Drug: mercaptopurine
Drug: methotrexate
Drug: mitoxantrone
Drug: Asparaginase
Drug: prednisone
Drug: thioguanine
Drug: vincristine
Radiation: radiation therapy
Drug: allopurinol
Drug: bactrim
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

Treatment included:

Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth

Period Title: Overall Study
Started 79
Eligible 78
Eligible and Ph- 61
Eligible and Ph- and Treated 60
Completed 56
Not Completed 23
Reason Not Completed
Adverse Event             2
Refusal unrelated to adverse effects             1
Death             1
BCR/ABL+ or Ph+             17
Not treated             1
Ineligible             1
Arm/Group Title Treatment
Hide Arm/Group Description

Treatment included:

Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
42
(18 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
20
  33.3%
Male
40
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Continuous Complete Remission at 1 Year
Hide Description A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.
Time Frame After induction, after consolidation, every 3 months during maintenance, and every three months after off treatment for up to a year
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible, Ph-, treated, and evaluable patients
Arm/Group Title Treatment
Hide Arm/Group Description:
Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
21
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment
Comments The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion in 1-year CCR
Estimated Value 0.36
Confidence Interval (1-Sided) 95%
0.25
Parameter Dispersion
Type: Standard Deviation
Value: 0.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Toxicity
Hide Description Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Time Frame Patients were assessed for adverse events after the induction cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started therapy
Arm/Group Title Induction
Hide Arm/Group Description:
One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: Participants with a given type of AE
ALT, SGPT (serum glutamic pyruvic transaminase) 17
AST, SGOT (serum glut oxaloacetic transaminase) 13
Albumin, serum-low (hypoalbuminemia) 3
Alkaline phosphatase 2
Anorexia 2
Ascites (non-malignant) 1
Bilirubin (hyperbilirubinemia) 6
Calcium, serum-low (hypocalcemia) 7
Cholecystitis 1
Cholesterol, serum-high (hypercholesterolemia) 2
Coagulation-Other (Specify) 1
Colitis, infectious (e.g., Clostridium difficile) 1
Constipation 1
DIC (disseminated intravascular coagulation) 2
Death not assoc with CTCAE term-Multi-organ fail 1
Edema: limb 1
Fatigue (asthenia, lethargy, malaise) 3
Febrile neutropenia 18
Fever (in the abs of neutropenia) 1
Fibrinogen 11
Glucose, serum-high (hyperglycemia) 16
Glucose, serum-low (hypoglycemia) 1
Hemoglobin 33
Hypertension 2
Hypotension 3
Hypoxia 2
Ileus, GI (functional obstruction of bowel) 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Anal 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Bladder 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Blood 11
Infec(doc clin or mibio) w/ Gr 3/4 neut-Bronchus 1
IInfec(doc clin or mibio) w/ Gr 3/4 neut-Catheter 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Eye NOS 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Lung 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Nose 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Pharynx 1
Infec(doc clin or mibio) w/ Gr 3/4 neut-Ur tract 2
Infec with nor ANC or Gr 1/2 neut-Lung (pneumonia) 2
Infection-Other (Specify) 1
Leukocytes (total WBC) 43
Lipase 1
Liver dysfunction/failure (clinical) 2
Lymphopenia 19
Magnesium, serum-high (hypermagnesemia) 1
Mucositis/stomatitis (clinical exam) - Oral cavity 2
Mucositis/stomatitis (funct/symp) - Oral cavity 1
Mucositis/stomatitis (func/symp) - Pharynx 1
Muscle weak,gen spec area-Whole body 2
Nausea 3
Neuropathy: motor 1
Neutrophils/granulocytes (ANC/AGC) 47
Pain - Abdomen NOS 1
Pain - Bone 1
Pain - Neck 1
Pancreatic endocrine: glucose intolerance 1
Pancreatitis 1
Phosphate, serum-low (hypophosphatemia) 1
Platelets 44
Potassium, serum-high (hyperkalemia) 1
Potassium, serum-low (hypokalemia) 7
Rash/desquamation 1
Renal failure 2
Sodium, serum-low (hyponatremia) 6
Thrombosis/thrombus/embolism 1
Thrombotic microangiopathy 2
Triglyceride, serum-high (hypertriglyceridemia) 1
Tumor lysis syndrome 5
Typhlitis (cecal inflammation) 1
Uric acid, serum-high (hyperuricemia) 1
Vomiting 1
Time Frame While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Adverse Event Reporting Description Regular investigator assessments are reported after each cycle of protocol treatment
 
Arm/Group Title First Induction Second Induction Consolidation Maintenance
Hide Arm/Group Description One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase. A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate
All-Cause Mortality
First Induction Second Induction Consolidation Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
First Induction Second Induction Consolidation Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/75 (2.67%)   2/56 (3.57%)   1/33 (3.03%)   0/12 (0.00%) 
Gastrointestinal disorders         
Pancreatitis  1  1/75 (1.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
General disorders         
Death not associated with CTCAE term - Multi-organ failure  1  1/75 (1.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood  1  0/75 (0.00%)  1/56 (1.79%)  0/33 (0.00%)  0/12 (0.00%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon  1  0/75 (0.00%)  1/56 (1.79%)  0/33 (0.00%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Hemorrhage/bleeding associated with surgery, intra-operative or post-operative  1  0/75 (0.00%)  1/56 (1.79%)  0/33 (0.00%)  0/12 (0.00%) 
Investigations         
Leukocytes (total WBC)  1  0/75 (0.00%)  0/56 (0.00%)  1/33 (3.03%)  0/12 (0.00%) 
Platelets  1  0/75 (0.00%)  0/56 (0.00%)  1/33 (3.03%)  0/12 (0.00%) 
Metabolism and nutrition disorders         
Triglyceride, serum-high (hypertriglyceridemia)  1  1/75 (1.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
First Induction Second Induction Consolidation Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   71/75 (94.67%)   54/56 (96.43%)   33/33 (100.00%)   11/12 (91.67%) 
Blood and lymphatic system disorders         
Febrile neutropenia  1  19/75 (25.33%)  30/56 (53.57%)  2/33 (6.06%)  0/12 (0.00%) 
Hemoglobin  1  43/75 (57.33%)  35/56 (62.50%)  21/33 (63.64%)  6/12 (50.00%) 
Cardiac disorders         
Palpitations  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Supraventricular and nodal arrhythmia - Sinus tachycardia  1  4/75 (5.33%)  5/56 (8.93%)  0/33 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders         
Constipation  1  27/75 (36.00%)  6/56 (10.71%)  3/33 (9.09%)  3/12 (25.00%) 
Diarrhea  1  18/75 (24.00%)  23/56 (41.07%)  2/33 (6.06%)  3/12 (25.00%) 
Distention/bloating, abdominal  1  5/75 (6.67%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Dry mouth/salivary gland (xerostomia)  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Gastrointestinal-Other (Specify)  1  0/75 (0.00%)  0/56 (0.00%)  2/33 (6.06%)  0/12 (0.00%) 
Heartburn/dyspepsia  1  6/75 (8.00%)  0/56 (0.00%)  2/33 (6.06%)  0/12 (0.00%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  6/75 (8.00%)  8/56 (14.29%)  0/33 (0.00%)  1/12 (8.33%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  5/75 (6.67%)  4/56 (7.14%)  0/33 (0.00%)  1/12 (8.33%) 
Nausea  1  31/75 (41.33%)  26/56 (46.43%)  14/33 (42.42%)  4/12 (33.33%) 
Pain - Abdomen NOS  1  6/75 (8.00%)  6/56 (10.71%)  0/33 (0.00%)  2/12 (16.67%) 
Pain - Oral cavity  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Vomiting  1  15/75 (20.00%)  19/56 (33.93%)  7/33 (21.21%)  3/12 (25.00%) 
General disorders         
Edema: limb  1  11/75 (14.67%)  7/56 (12.50%)  0/33 (0.00%)  0/12 (0.00%) 
Fatigue (asthenia, lethargy, malaise)  1  37/75 (49.33%)  36/56 (64.29%)  19/33 (57.58%)  7/12 (58.33%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)  1  4/75 (5.33%)  12/56 (21.43%)  4/33 (12.12%)  3/12 (25.00%) 
Pain - Pain NOS  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Pain-Other (Specify)  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  2/12 (16.67%) 
Rigors/chills  1  11/75 (14.67%)  22/56 (39.29%)  0/33 (0.00%)  0/12 (0.00%) 
Hepatobiliary disorders         
Liver dysfunction/failure (clinical)  1  4/75 (5.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Colitis, infectious (e.g., Clostridium difficile)  1  0/75 (0.00%)  3/56 (5.36%)  0/33 (0.00%)  1/12 (8.33%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood  1  11/75 (14.67%)  11/56 (19.64%)  0/33 (0.00%)  0/12 (0.00%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin (celluli  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Infection with unknown ANC - Mucosa  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Investigations         
ALT, SGPT (serum glutamic pyruvic transaminase)  1  38/75 (50.67%)  27/56 (48.21%)  9/33 (27.27%)  3/12 (25.00%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  37/75 (49.33%)  22/56 (39.29%)  8/33 (24.24%)  3/12 (25.00%) 
Alkaline phosphatase  1  21/75 (28.00%)  9/56 (16.07%)  0/33 (0.00%)  3/12 (25.00%) 
Amylase  1  4/75 (5.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  28/75 (37.33%)  15/56 (26.79%)  5/33 (15.15%)  1/12 (8.33%) 
CPK (creatine phosphokinase)  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Creatinine  1  8/75 (10.67%)  5/56 (8.93%)  2/33 (6.06%)  0/12 (0.00%) 
Fibrinogen  1  14/75 (18.67%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Leukocytes (total WBC)  1  43/75 (57.33%)  34/56 (60.71%)  21/33 (63.64%)  9/12 (75.00%) 
Lymphopenia  1  20/75 (26.67%)  15/56 (26.79%)  9/33 (27.27%)  3/12 (25.00%) 
Metabolic/Laboratory-Other (Specify)  1  5/75 (6.67%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Neutrophils/granulocytes (ANC/AGC)  1  49/75 (65.33%)  39/56 (69.64%)  28/33 (84.85%)  8/12 (66.67%) 
PTT (Partial thromboplastin time)  1  5/75 (6.67%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Platelets  1  48/75 (64.00%)  43/56 (76.79%)  24/33 (72.73%)  7/12 (58.33%) 
Weight loss  1  10/75 (13.33%)  8/56 (14.29%)  0/33 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders         
Albumin, serum-low (hypoalbuminemia)  1  18/75 (24.00%)  23/56 (41.07%)  8/33 (24.24%)  2/12 (16.67%) 
Anorexia  1  11/75 (14.67%)  14/56 (25.00%)  5/33 (15.15%)  2/12 (16.67%) 
Calcium, serum-low (hypocalcemia)  1  29/75 (38.67%)  20/56 (35.71%)  4/33 (12.12%)  0/12 (0.00%) 
Dehydration  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Glucose, serum-high (hyperglycemia)  1  30/75 (40.00%)  16/56 (28.57%)  5/33 (15.15%)  2/12 (16.67%) 
Glucose, serum-low (hypoglycemia)  1  4/75 (5.33%)  0/56 (0.00%)  2/33 (6.06%)  0/12 (0.00%) 
Magnesium, serum-high (hypermagnesemia)  1  5/75 (6.67%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Magnesium, serum-low (hypomagnesemia)  1  0/75 (0.00%)  6/56 (10.71%)  3/33 (9.09%)  0/12 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  0/75 (0.00%)  3/56 (5.36%)  0/33 (0.00%)  0/12 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  6/75 (8.00%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Potassium, serum-low (hypokalemia)  1  19/75 (25.33%)  14/56 (25.00%)  6/33 (18.18%)  2/12 (16.67%) 
Sodium, serum-high (hypernatremia)  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Sodium, serum-low (hyponatremia)  1  16/75 (21.33%)  13/56 (23.21%)  3/33 (9.09%)  0/12 (0.00%) 
Tumor lysis syndrome  1  5/75 (6.67%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Uric acid, serum-high (hyperuricemia)  1  4/75 (5.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthritis (non-septic)  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized  1  9/75 (12.00%)  3/56 (5.36%)  4/33 (12.12%)  0/12 (0.00%) 
Pain - Back  1  4/75 (5.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Pain - Bone  1  0/75 (0.00%)  3/56 (5.36%)  0/33 (0.00%)  1/12 (8.33%) 
Pain - Joint  1  4/75 (5.33%)  0/56 (0.00%)  0/33 (0.00%)  0/12 (0.00%) 
Pain - Muscle  1  0/75 (0.00%)  4/56 (7.14%)  0/33 (0.00%)  1/12 (8.33%) 
Nervous system disorders         
Dizziness  1  8/75 (10.67%)  6/56 (10.71%)  2/33 (6.06%)  2/12 (16.67%) 
Neuropathy: motor  1  4/75 (5.33%)  0/56 (0.00%)  2/33 (6.06%)  1/12 (8.33%) 
Neuropathy: sensory  1  24/75 (32.00%)  15/56 (26.79%)  4/33 (12.12%)  5/12 (41.67%) 
Pain - Head/headache  1  13/75 (17.33%)  14/56 (25.00%)  8/33 (24.24%)  4/12 (33.33%) 
Taste alteration (dysgeusia)  1  0/75 (0.00%)  4/56 (7.14%)  0/33 (0.00%)  2/12 (16.67%) 
Tremor  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Psychiatric disorders         
Insomnia  1  14/75 (18.67%)  4/56 (7.14%)  0/33 (0.00%)  2/12 (16.67%) 
Mood alteration - anxiety  1  5/75 (6.67%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Mood alteration - depression  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  2/12 (16.67%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/75 (0.00%)  5/56 (8.93%)  2/33 (6.06%)  1/12 (8.33%) 
Dyspnea (shortness of breath)  1  6/75 (8.00%)  7/56 (12.50%)  3/33 (9.09%)  2/12 (16.67%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  5/75 (6.67%)  5/56 (8.93%)  0/33 (0.00%)  0/12 (0.00%) 
Mucositis/stomatitis (clinical exam) - Pharynx  1  0/75 (0.00%)  5/56 (8.93%)  0/33 (0.00%)  0/12 (0.00%) 
Mucositis/stomatitis (functional/symptomatic) - Pharynx  1  4/75 (5.33%)  6/56 (10.71%)  0/33 (0.00%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders         
Dry skin  1  0/75 (0.00%)  0/56 (0.00%)  2/33 (6.06%)  0/12 (0.00%) 
Hair loss/Alopecia (scalp or body)  1  28/75 (37.33%)  17/56 (30.36%)  4/33 (12.12%)  3/12 (25.00%) 
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  0/75 (0.00%)  3/56 (5.36%)  4/33 (12.12%)  0/12 (0.00%) 
Pruritus/itching  1  0/75 (0.00%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Rash/desquamation  1  5/75 (6.67%)  11/56 (19.64%)  0/33 (0.00%)  2/12 (16.67%) 
Sweating (diaphoresis)  1  0/75 (0.00%)  5/56 (8.93%)  0/33 (0.00%)  0/12 (0.00%) 
Vascular disorders         
Hemorrhage/Bleeding-Other (Specify)  1  0/75 (0.00%)  3/56 (5.36%)  0/33 (0.00%)  0/12 (0.00%) 
Hypertension  1  5/75 (6.67%)  0/56 (0.00%)  0/33 (0.00%)  1/12 (8.33%) 
Hypotension  1  5/75 (6.67%)  11/56 (19.64%)  0/33 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT 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
Layout table for Results Point of Contact information
Name/Title: SWOG Leukemia Statistician
Organization: SWOG Statistical Office
Phone: 206-667-4408
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00109837     History of Changes
Other Study ID Numbers: S0333
U10CA032102 ( U.S. NIH Grant/Contract )
S0333 ( Other Identifier: SWOG )
First Submitted: May 3, 2005
First Posted: May 4, 2005
Results First Submitted: April 4, 2012
Results First Posted: August 23, 2012
Last Update Posted: March 25, 2015