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S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML

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ClinicalTrials.gov Identifier: NCT00085709
Recruitment Status : Completed
First Posted : June 16, 2004
Results First Posted : August 27, 2012
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: gemtuzumab ozogamicin
Other: observation
Drug: Cytosine arabinoside
Drug: Daunomycin
Enrollment 637
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ara-C+Daunomycin+Mylotarg ARA-C+Daunomycin
Hide Arm/Group Description Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin Standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
Period Title: Overall Study
Started 317 320
Eligible 298 301
Eligible and Did Not Withdraw Consent 296 300
Completed 264 270
Not Completed 53 50
Reason Not Completed
Adverse Event             8             0
Death             8             2
Refusal unrelated to adverse events             1             2
Progression             3             4
Not protocol specified             12             22
Not eligible             19             19
Withdrawal by Subject             2             1
Arm/Group Title Ara-C+Daunomycin+Mylotarg ARA-C+Daunomycin Total
Hide Arm/Group Description Ara-C+Daunomycin+Mylotarg ARA-C+Daunomycin Total of all reporting groups
Overall Number of Baseline Participants 296 300 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 296 participants 300 participants 596 participants
47
(18 to 60)
48
(18 to 60)
47
(18 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 300 participants 596 participants
Female
135
  45.6%
148
  49.3%
283
  47.5%
Male
161
  54.4%
152
  50.7%
313
  52.5%
1.Primary Outcome
Title 2-year Disease-free Survival (DFS)
Hide Description Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.
Time Frame After completing any treatment, every 6 months for 2 years, than annually for years 3-5
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who completed induction and consolidation therapy
Arm/Group Title Post-consolidation GO Post-consolidation Observation
Hide Arm/Group Description:
For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
Patients did not receive any post-consolidation therapy
Overall Number of Participants Analyzed 84 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of population
39
(27 to 51)
50
(38 to 62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Post-consolidation GO, Post-consolidation Observation
Comments Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.
2.Primary Outcome
Title Complete Remission
Hide Description [Not Specified]
Time Frame After induction therapy was completed (1 or 2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who did not withdraw consent
Arm/Group Title Ara-C+Daunomycin Ara-C+Daunomycin+Mylotarg
Hide Arm/Group Description:
A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
Overall Number of Participants Analyzed 296 300
Measure Type: Number
Unit of Measure: participants
203 207
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ara-C+Daunomycin, Ara-C+Daunomycin+Mylotarg
Comments Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0025
Comments [Not Specified]
Method Test of difference of proportions
Comments [Not Specified]
3.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 For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started therapy
Arm/Group Title Ara-C+Daunomycin+Mylotarg Ara-C+Daunomycin Ara-C Consolidation Post-consolidation G.O.
Hide Arm/Group Description:
A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
Overall Number of Participants Analyzed 293 294 377 79
Measure Type: Number
Unit of Measure: Participants with a given type of AE
ALT, SGPT (serum glutamic pyruvic transaminase) 29 11 22 2
AST, SGOT (serum glut. oxaloacetic transaminase) 32 11 17 2
Acidosis (metabolic or respiratory) 2 0 2 0
Adult respiratory distress syndrome (ARDS) 7 0 2 0
Albumin, serum-low (hypoalbuminemia) 15 10 3 0
Alkaline phosphatase 3 2 2 0
Alkalosis (metabolic or respiratory) 1 1 0 0
Allergic reaction/hypersens. (inc drug fever) 6 0 0 0
Amylase 0 0 1 0
Anorexia 14 13 2 0
Apnea 0 0 1 0
Ataxia (incoordination) 0 0 2 0
Bicarbonate, serum-low 1 0 0 0
Bilirubin (hyperbilirubinemia) 14 11 4 0
Blood/Bone Marrow-Other (Specify) 0 1 2 0
Bronchospasm, wheezing 1 0 0 0
Calcium, serum-low (hypocalcemia) 13 7 3 0
Cardiac Arrhythmia-Other (Specify) 0 0 1 0
Cardiac General-Other (Specify) 0 2 0 0
Cardiac troponin I (cTnI) 0 1 0 0
Cardiac troponin T (cTnT) 0 0 3 0
Cardiac-ischemia/infarction 2 1 4 0
Colitis 2 6 1 0
Colitis, infectious (e.g., Clostridium difficile) 8 10 4 0
Confusion 3 1 0 0
Constipation 1 0 0 0
Cough 0 0 1 0
Creatinine 3 2 0 0
DIC (disseminated intravascular coagulation) 2 0 0 0
Death not assoc with CTCAE term-Multi-organ failu 1 0 0 0
Dehydration 0 0 1 1
Diarrhea 5 19 4 0
Distention/bloating, abdominal 0 0 1 0
Dizziness 2 0 3 0
Dysphagia (difficulty swallowing) 1 1 0 0
Dyspnea (shortness of breath) 10 6 10 0
Edema, larynx 1 1 0 0
Edema: limb 0 0 1 0
Edema: viscera 1 0 0 0
Enteritis (inflammation of the small bowel) 1 0 0 0
Esophagitis 1 3 0 0
Fatigue (asthenia, lethargy, malaise) 24 25 22 4
Febrile neutropenia 178 196 183 22
Fever (in the absence of neutropenia) 6 8 16 1
Fistula, GI - Rectum 1 0 0 0
Fistula, GU - Vagina 1 0 0 0
Flu-like syndrome 0 0 1 0
GGT (gamma-glutamyl transpeptidase) 1 0 4 0
Glucose, serum-high (hyperglycemia) 22 12 15 2
Glucose, serum-low (hypoglycemia) 1 0 0 0
Hematoma 1 1 1 0
Hemoglobin 101 87 144 2
Hemolysis 0 0 1 0
Hemorrhage, CNS 5 1 0 0
Hemorrhage, GI - Abdomen NOS 0 1 0 0
Hemorrhage, GI - Jejunum 1 0 0 0
Hemorrhage, GI - Lower GI NOS 0 0 1 0
Hemorrhage, GI - Oral cavity 1 0 2 0
Hemorrhage, GI - Rectum 1 1 0 0
Hemorrhage, GU - Bladder 2 0 0 0
Hemorrhage, GU - Kidney 1 0 0 0
Hemorrhage, GU - Urinary NOS 1 0 0 0
Hemorrhage, GU - Uterus 0 2 0 0
Hemorrhage, GU - Vagina 1 1 1 0
Hemorrhage, pulmonary/upper respiratory - Lung 5 0 0 0
Hemorrhage, pulmonary/upper respiratory - Nose 3 1 4 0
Hemorrhage/Bleeding-Other (Specify) 8 5 12 0
Hepatobiliary/Pancreas-Other (Specify) 3 0 0 0
Hiccoughs (hiccups, singultus) 0 1 0 0
Hypertension 2 3 2 0
Hypotension 5 1 4 1
Hypoxia 8 2 6 0
Infec with Grade 3 or 4 neut - Abdomen NOS 1 0 0 0
Infec with Grade 3 or 4 neut - Anal/perianal 0 2 4 0
Infec with Grade 3 or 4 neut - Appendix 0 1 0 0
Infec with Grade 3 or 4 neut - Bladder (urin 2 1 4 0
Infec with Grade 3 or 4 neut - Blood 30 25 47 4
Infec with Grade 3 or 4 neut - Bone (osteomy 0 0 1 0
Infec with Grade 3 or 4 neut - Brain + Spina 0 1 0 0
Infec with Grade 3 or 4 neut - Bronchus 0 1 1 0
Infec with Grade 3 or 4 neut - Catheter-rela 5 6 13 2
Infec with Grade 3 or 4 neut - Cecum 0 0 1 0
Infec with Grade 3 or 4 neut - Colon 5 2 2 0
Infec with Grade 3 or 4 neut - Dental-tooth 1 2 3 0
Infec with Grade 3 or 4 neut - Heart (endoca 1 1 0 0
Infec with Grade 3 or 4 neut - Lip/perioral 1 0 0 0
Infec with Grade 3 or 4 neut - Liver 0 1 1 0
Infec with Grade 3 or 4 neut - Lung (pneumon 22 27 22 0
Infec with Grade 3 or 4 neut - Meninges (men 0 0 1 0
Infect with Grade 3 or 4 neut - Mucosa 1 2 1 0
Infec with Grade 3 or 4 neut - Nerve-periphe 1 0 0 0
Infec with Grade 3 or 4 neut - Oral cavity-g 2 3 2 0
Infec with Grade 3 or 4 neut - Pelvis NOS 1 0 0 0
Infec with Grade 3 or 4 neut- Pharynx 0 1 1 1
Infec with Grade 3 or 4 neut - Rectum 0 1 0 0
Infec with Grade 3 or 4 neut - Sinus 2 3 2 0
Infec with Grade 3 or 4 neut - Skin (celluli 4 3 9 1
Infec with Grade 3 or 4 neut - Small bowel N 0 1 1 0
Infec with Grade 3 or 4 neut - Upper airway 1 0 0 0
Infection with Grade 3 or 4 neut - Urinary tract 6 6 6 0
Infec with Grade 3 or 4 neut - Vulva 0 0 1 0
Infec with Grade 3 or 4 neut - Wound 1 0 0 0
Infec with normal ANC or Grade 1/2 neut - Blood 0 0 6 0
Infec with norm ANC or Gr 1/2 neut, Catheter-rel 0 1 4 0
Infec with norm ANC or Grade 1/2 neut - Colon 0 0 1 0
Infec with norm ANC or Gr 1/2 neutr- Dental-tooth 1 0 0 0
Infec with norm ANC or Gr 1/2 neut - Heart 0 0 1 0
Infec with norm ANC or Gr 1/2 neutrophils - Liver 1 0 0 0
Infec with norm ANC or Gr 1/2 neut-Lung (pneumoni) 6 0 9 0
Infec with norm ANC or Gr 1/2 neut - Muscle 1 0 0 0
Inf with norm ANC or Gr 1/2 neut-Oral cavity-gums 0 1 0 0
Infec with norm ANC or Gr 1/2 neut - Scrotum 0 0 1 0
Infec with norm ANC or Gr 1/2 neut-Skin 2 0 0 0
Infec with norm ANC or Gr 1/2 neut-Urinary tract 0 1 0 0
Infection with unknown ANC - Blood 0 3 7 0
Infection with unknown ANC - Catheter-related 3 1 1 0
Infection with unknown ANC - Dental-tooth 0 1 0 0
Infection with unknown ANC - Joint 0 0 2 0
Infection with unknown ANC - Liver 0 0 1 0
Infection with unknown ANC - Lung (pneumonia) 0 2 2 0
Infection with unknown ANC - Mucosa 0 0 1 0
Infection with unknown ANC - Sinus 1 1 0 0
Infection with unknown ANC - Skin (cellulitis) 4 3 3 0
Infection with unknown ANC - Urinary tract NOS 1 1 0 0
Infection with unknown ANC - Wound 0 1 0 0
Infection-Other (Specify) 4 4 4 0
Left ventricular diastolic dysfunction 0 0 1 0
Left ventricular systolic dysfunction 1 1 2 0
Leukocytes (total WBC) 106 96 151 41
Leukoencephalopathy (radiolographic findings) 0 0 1 0
Liver dysfunction/failure (clinical) 4 1 0 0
Lymphopenia 21 23 50 4
Magnesium, serum-low (hypomagnesemia) 1 1 1 0
Metabolic/Laboratory-Other (Specify) 3 5 4 0
Mood alteration - anxiety 1 0 1 0
Mood alteration - depression 0 1 0 0
Mucositis/stomatitis (clinical exam) - Esophagus 0 1 0 0
Mucositis/stomatitis (clinical exam) - Large bowel 0 1 0 0
Mucositis/stomatitis (clinical exam) - Larynx 0 1 0 0
Mucositis/stomatitis (clinical exam) - Oral cavity 6 11 2 0
Mucositis/stomatitis (clinical exam) - Pharynx 2 2 0 0
Mucositis/stomatitis (func/sympt) - Esophagus 0 2 0 0
Mucositis/stomatitis (func/sympt)- Oral cavity 4 9 1 0
Mucositis/stomatitis (func/sympt) - Pharynx 1 2 1 0
Muscle weakness (func/sym, Whole body/generalized 0 1 2 0
Nasal cavity/paranasal sinus reactions 1 0 0 0
Nausea 7 13 7 1
Necrosis, GI - Rectum 0 0 1 0
Neurology-Other (Specify) 1 1 1 0
Neuropathy: motor 0 0 2 0
Neuropathy: sensory 1 0 1 0
Neutrophils/granulocytes (ANC/AGC) 111 110 193 43
Nystagmus 0 1 0 0
Obstruction/stenosis of airway - Trachea 0 0 1 0
Ocular/Visual-Other (Specify) 0 1 0 0
Opportunistic infec assoc with Gr 2 lymphopenia 0 2 0 1
PTT (Partial thromboplastin time) 0 0 1 0
Pain - Abdomen NOS 8 5 3 0
Pain - Anus 0 0 1 1
Pain - Back 1 0 1 1
Pain - Bone 0 0 4 0
Pain - Chest/thorax NOS 2 1 2 0
Pain - Extremity-limb 0 1 1 1
Pain - Eye 0 0 1 0
Pain - Head/headache 8 1 8 1
Pain - Joint 1 0 0 0
Pain - Muscle 0 0 1 0
Pain - Oral-gums 0 1 0 0
Pain - Rectum 0 0 0 1
Pain - Throat/pharynx/larynx 0 1 0 0
Pain-Other (Specify) 1 0 0 0
Pancreatic endocrine: glucose intolerance 1 0 0 0
Perforation, GI - Colon 0 1 0 0
Pericardial effusion (non-malignant) 1 0 0 0
Pericarditis 1 0 0 0
Petechiae/purpura 6 2 3 1
Phosphate, serum-low (hypophosphatemia) 10 9 6 1
Platelets 145 130 226 40
Pleural effusion (non-malignant) 1 1 3 0
Pneumonitis/pulmonary infiltrates 3 1 5 0
Portal vein flow 2 0 0 0
Potassium, serum-high (hyperkalemia) 4 2 0 0
Potassium, serum-low (hypokalemia) 21 15 19 3
Proctitis 0 1 0 0
Pulmonary/Upper Respiratory-Other (Specify) 1 0 1 0
Rash/desquamation 6 9 1 0
Renal failure 8 6 0 0
Rigors/chills 0 0 1 0
Seroma 1 0 0 0
Serum sickness 0 0 0 1
Sodium, serum-high (hypernatremia) 2 0 0 0
Sodium, serum-low (hyponatremia) 8 15 4 0
Somnolence/depressed level of consciousness 1 0 0 0
Atrial fibrillation 0 1 0 0
Sinus tachycardia 1 0 0 0
Supraventricular arrhythmia NOS 1 0 0 0
Syncope (fainting) 1 3 4 0
Syndromes-Other (Specify) 0 0 2 0
Thrombosis/embolism (vascular access-related) 0 1 1 0
Thrombosis/thrombus/embolism 4 4 4 0
Thrombotic microangiopathy 0 1 0 0
Tumor lysis syndrome 2 2 0 0
Typhlitis (cecal inflammation) 3 4 1 0
Uric acid, serum-high (hyperuricemia) 1 0 1 0
Vasovagal episode 0 0 1 0
Ventricular arrhythmia - Ventricular fibrillation 1 0 0 0
Vision-blurred vision 0 1 0 0
Vomiting 2 5 5 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 Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
Hide Arm/Group Description A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment. For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
All-Cause Mortality
Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/293 (16.04%)      9/293 (3.07%)      13/375 (3.47%)      19/78 (24.36%)    
Blood and lymphatic system disorders         
DIC (disseminated intravascular coagulation)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Febrile neutropenia  1  7/293 (2.39%)  7 1/293 (0.34%)  1 4/375 (1.07%)  4 9/78 (11.54%)  9
Hemoglobin  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Cardiac disorders         
Cardiac-ischemia/infarction  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Pericardial effusion (non-malignant)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Pericarditis  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Gastrointestinal disorders         
Colitis  1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/375 (0.00%)  0 0/78 (0.00%)  0
Mucositis/stomatitis (clinical exam) - Oral cavity  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
Nausea  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
Pain - Rectum  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
Perforation, GI - Colon  1  0/293 (0.00%)  0 1/293 (0.34%)  1 0/375 (0.00%)  0 0/78 (0.00%)  0
Typhlitis (cecal inflammation)  1  1/293 (0.34%)  1 1/293 (0.34%)  1 0/375 (0.00%)  0 0/78 (0.00%)  0
Vomiting  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
General disorders         
Death not associated with CTCAE term - Multi-organ failure  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Syndromes-Other (Specify)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Hepatobiliary disorders         
Hepatobiliary/Pancreas-Other (Specify)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Liver dysfunction/failure (clinical)  1  4/293 (1.37%)  4 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Portal vein flow  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Immune system disorders         
Allergic reaction/hypersensitivity (including drug fever)  1  2/293 (0.68%)  2 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Infections and infestations         
Colitis, infectious (e.g., Clostridium difficile)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood  1  8/293 (2.73%)  8 2/293 (0.68%)  2 1/375 (0.27%)  1 3/78 (3.85%)  3
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Colon  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Heart (endoca  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon  1  3/293 (1.02%)  3 1/293 (0.34%)  1 1/375 (0.27%)  1 0/78 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Pelvis NOS  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin (celluli  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
Infection-Other (Specify)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
Investigations         
ALT, SGPT (serum glutamic pyruvic transaminase)  1  5/293 (1.71%)  5 0/293 (0.00%)  0 1/375 (0.27%)  1 1/78 (1.28%)  1
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  4/293 (1.37%)  4 0/293 (0.00%)  0 1/375 (0.27%)  1 1/78 (1.28%)  1
Alkaline phosphatase  1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  3/293 (1.02%)  3 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Creatinine  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Leukocytes (total WBC)  1  5/293 (1.71%)  5 0/293 (0.00%)  0 1/375 (0.27%)  1 2/78 (2.56%)  2
Metabolic/Laboratory-Other (Specify)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC)  1  3/293 (1.02%)  3 0/293 (0.00%)  0 1/375 (0.27%)  1 5/78 (6.41%)  5
Platelets  1  9/293 (3.07%)  9 1/293 (0.34%)  1 1/375 (0.27%)  1 2/78 (2.56%)  2
Metabolism and nutrition disorders         
Calcium, serum-low (hypocalcemia)  1  3/293 (1.02%)  3 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Dehydration  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
Glucose, serum-high (hyperglycemia)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 1/78 (1.28%)  1
Glucose, serum-low (hypoglycemia)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Pancreatic endocrine: glucose intolerance  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  1/293 (0.34%)  1 1/293 (0.34%)  1 0/375 (0.00%)  0 0/78 (0.00%)  0
Uric acid, serum-high (hyperuricemia)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Pain - Joint  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Nervous system disorders         
Hemorrhage, CNS  1  5/293 (1.71%)  5 1/293 (0.34%)  1 0/375 (0.00%)  0 0/78 (0.00%)  0
Leukoencephalopathy (radiolographic findings)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Neurology-Other (Specify)  1  1/293 (0.34%)  1 1/293 (0.34%)  1 0/375 (0.00%)  0 0/78 (0.00%)  0
Renal and urinary disorders         
Hemorrhage, GU - Bladder  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Hemorrhage, GU - Kidney  1  2/293 (0.68%)  2 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Adult respiratory distress syndrome (ARDS)  1  5/293 (1.71%)  5 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Dyspnea (shortness of breath)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory - Lung  1  5/293 (1.71%)  5 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Hypoxia  1  4/293 (1.37%)  4 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Pleural effusion (non-malignant)  1  2/293 (0.68%)  2 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Pneumonitis/pulmonary infiltrates  1  2/293 (0.68%)  2 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Pulmonary/Upper Respiratory-Other (Specify)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Skin and subcutaneous tissue disorders         
Rash/desquamation  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Vascular disorders         
Hemorrhage/Bleeding-Other (Specify)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Hypotension  1  1/293 (0.34%)  1 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
Phlebitis (including superficial thrombosis)  1  1/293 (0.34%)  1 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Thrombosis/thrombus/embolism  1  0/293 (0.00%)  0 0/293 (0.00%)  0 1/375 (0.27%)  1 0/78 (0.00%)  0
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%
Induction 7 + 3 + G.O. Induction 7 + 3 Ara-C Consolidation Post-consolidation G.O.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   277/293 (94.54%)      279/293 (95.22%)      356/375 (94.93%)      77/78 (98.72%)    
Blood and lymphatic system disorders         
Febrile neutropenia  1  172/293 (58.70%)  172 194/293 (66.21%)  194 178/375 (47.47%)  178 14/78 (17.95%)  14
Hemoglobin  1  116/293 (39.59%)  116 109/293 (37.20%)  109 201/375 (53.60%)  201 27/78 (34.62%)  27
Eye disorders         
Vision-blurred vision  1  0/293 (0.00%)  0 0/293 (0.00%)  0 19/375 (5.07%)  19 0/78 (0.00%)  0
Gastrointestinal disorders         
Constipation  1  36/293 (12.29%)  36 32/293 (10.92%)  32 46/375 (12.27%)  46 5/78 (6.41%)  5
Diarrhea  1  115/293 (39.25%)  115 130/293 (44.37%)  130 76/375 (20.27%)  76 9/78 (11.54%)  9
Heartburn/dyspepsia  1  0/293 (0.00%)  0 25/293 (8.53%)  25 20/375 (5.33%)  20 0/78 (0.00%)  0
Hemorrhage, GI - Oral cavity  1  0/293 (0.00%)  0 0/293 (0.00%)  0 19/375 (5.07%)  19 0/78 (0.00%)  0
Mucositis/stomatitis (clinical exam) - Oral cavity  1  76/293 (25.94%)  76 64/293 (21.84%)  64 63/375 (16.80%)  63 8/78 (10.26%)  8
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  33/293 (11.26%)  33 37/293 (12.63%)  37 35/375 (9.33%)  35 0/78 (0.00%)  0
Nausea  1  165/293 (56.31%)  165 159/293 (54.27%)  159 182/375 (48.53%)  182 40/78 (51.28%)  40
Pain - Abdomen NOS  1  51/293 (17.41%)  51 35/293 (11.95%)  35 31/375 (8.27%)  31 8/78 (10.26%)  8
Vomiting  1  93/293 (31.74%)  93 75/293 (25.60%)  75 97/375 (25.87%)  97 22/78 (28.21%)  22
General disorders         
Edema: limb  1  38/293 (12.97%)  38 24/293 (8.19%)  24 27/375 (7.20%)  27 0/78 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  140/293 (47.78%)  140 142/293 (48.46%)  142 210/375 (56.00%)  210 41/78 (52.56%)  41
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)  1  56/293 (19.11%)  56 55/293 (18.77%)  55 97/375 (25.87%)  97 14/78 (17.95%)  14
Rigors/chills  1  71/293 (24.23%)  71 55/293 (18.77%)  55 56/375 (14.93%)  56 8/78 (10.26%)  8
Immune system disorders         
Allergic reaction/hypersensitivity (including drug fever)  1  15/293 (5.12%)  15 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Infections and infestations         
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood  1  23/293 (7.85%)  23 24/293 (8.19%)  24 47/375 (12.53%)  47 0/78 (0.00%)  0
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung (pneumon  1  22/293 (7.51%)  22 26/293 (8.87%)  26 23/375 (6.13%)  23 0/78 (0.00%)  0
Investigations         
ALT, SGPT (serum glutamic pyruvic transaminase)  1  124/293 (42.32%)  124 90/293 (30.72%)  90 137/375 (36.53%)  137 34/78 (43.59%)  34
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  126/293 (43.00%)  126 92/293 (31.40%)  92 121/375 (32.27%)  121 33/78 (42.31%)  33
Alkaline phosphatase  1  79/293 (26.96%)  79 60/293 (20.48%)  60 84/375 (22.40%)  84 22/78 (28.21%)  22
Bilirubin (hyperbilirubinemia)  1  51/293 (17.41%)  51 63/293 (21.50%)  63 75/375 (20.00%)  75 0/78 (0.00%)  0
Creatinine  1  34/293 (11.60%)  34 19/293 (6.48%)  19 23/375 (6.13%)  23 0/78 (0.00%)  0
Leukocytes (total WBC)  1  101/293 (34.47%)  101 97/293 (33.11%)  97 152/375 (40.53%)  152 40/78 (51.28%)  40
Lymphopenia  1  32/293 (10.92%)  32 27/293 (9.22%)  27 50/375 (13.33%)  50 10/78 (12.82%)  10
Metabolic/Laboratory-Other (Specify)  1  16/293 (5.46%)  16 0/293 (0.00%)  0 21/375 (5.60%)  21 0/78 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC)  1  109/293 (37.20%)  109 111/293 (37.88%)  111 195/375 (52.00%)  195 40/78 (51.28%)  40
Platelets  1  136/293 (46.42%)  136 130/293 (44.37%)  130 227/375 (60.53%)  227 49/78 (62.82%)  49
Metabolism and nutrition disorders         
Albumin, serum-low (hypoalbuminemia)  1  69/293 (23.55%)  69 53/293 (18.09%)  53 81/375 (21.60%)  81 6/78 (7.69%)  6
Anorexia  1  85/293 (29.01%)  85 75/293 (25.60%)  75 76/375 (20.27%)  76 9/78 (11.54%)  9
Calcium, serum-low (hypocalcemia)  1  44/293 (15.02%)  44 53/293 (18.09%)  53 44/375 (11.73%)  44 5/78 (6.41%)  5
Glucose, serum-high (hyperglycemia)  1  79/293 (26.96%)  79 71/293 (24.23%)  71 97/375 (25.87%)  97 21/78 (26.92%)  21
Magnesium, serum-low (hypomagnesemia)  1  17/293 (5.80%)  17 0/293 (0.00%)  0 25/375 (6.67%)  25 0/78 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  17/293 (5.80%)  17 18/293 (6.14%)  18 0/375 (0.00%)  0 0/78 (0.00%)  0
Potassium, serum-high (hyperkalemia)  1  20/293 (6.83%)  20 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Potassium, serum-low (hypokalemia)  1  55/293 (18.77%)  55 44/293 (15.02%)  44 61/375 (16.27%)  61 12/78 (15.38%)  12
Sodium, serum-low (hyponatremia)  1  42/293 (14.33%)  42 41/293 (13.99%)  41 39/375 (10.40%)  39 8/78 (10.26%)  8
Uric acid, serum-high (hyperuricemia)  1  0/293 (0.00%)  0 0/293 (0.00%)  0 20/375 (5.33%)  20 0/78 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized  1  0/293 (0.00%)  0 0/293 (0.00%)  0 0/375 (0.00%)  0 4/78 (5.13%)  4
Pain - Bone  1  0/293 (0.00%)  0 15/293 (5.12%)  15 40/375 (10.67%)  40 8/78 (10.26%)  8
Pain - Joint  1  0/293 (0.00%)  0 0/293 (0.00%)  0 21/375 (5.60%)  21 4/78 (5.13%)  4
Pain - Muscle  1  0/293 (0.00%)  0 0/293 (0.00%)  0 19/375 (5.07%)  19 0/78 (0.00%)  0
Nervous system disorders         
Dizziness  1  0/293 (0.00%)  0 0/293 (0.00%)  0 42/375 (11.20%)  42 0/78 (0.00%)  0
Pain - Head/headache  1  72/293 (24.57%)  72 48/293 (16.38%)  48 94/375 (25.07%)  94 9/78 (11.54%)  9
Taste alteration (dysgeusia)  1  18/293 (6.14%)  18 16/293 (5.46%)  16 0/375 (0.00%)  0 0/78 (0.00%)  0
Psychiatric disorders         
Insomnia  1  0/293 (0.00%)  0 0/293 (0.00%)  0 25/375 (6.67%)  25 0/78 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  15/293 (5.12%)  15 0/293 (0.00%)  0 20/375 (5.33%)  20 0/78 (0.00%)  0
Dyspnea (shortness of breath)  1  33/293 (11.26%)  33 20/293 (6.83%)  20 59/375 (15.73%)  59 0/78 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory - Nose  1  37/293 (12.63%)  37 24/293 (8.19%)  24 26/375 (6.93%)  26 6/78 (7.69%)  6
Skin and subcutaneous tissue disorders         
Hair loss/Alopecia (scalp or body)  1  76/293 (25.94%)  76 98/293 (33.45%)  98 118/375 (31.47%)  118 8/78 (10.26%)  8
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  53/293 (18.09%)  53 45/293 (15.36%)  45 85/375 (22.67%)  85 0/78 (0.00%)  0
Pruritus/itching  1  0/293 (0.00%)  0 15/293 (5.12%)  15 20/375 (5.33%)  20 0/78 (0.00%)  0
Rash/desquamation  1  51/293 (17.41%)  51 64/293 (21.84%)  64 62/375 (16.53%)  62 6/78 (7.69%)  6
Vascular disorders         
Hemorrhage/Bleeding-Other (Specify)  1  27/293 (9.22%)  27 15/293 (5.12%)  15 29/375 (7.73%)  29 0/78 (0.00%)  0
Hypertension  1  21/293 (7.17%)  21 0/293 (0.00%)  0 0/375 (0.00%)  0 0/78 (0.00%)  0
Hypotension  1  17/293 (5.80%)  17 15/293 (5.12%)  15 28/375 (7.47%)  28 0/78 (0.00%)  0
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
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00085709     History of Changes
Other Study ID Numbers: S0106
U10CA032102 ( U.S. NIH Grant/Contract )
S0106 ( Other Identifier: SWOG )
First Submitted: June 14, 2004
First Posted: June 16, 2004
Results First Submitted: June 5, 2012
Results First Posted: August 27, 2012
Last Update Posted: September 30, 2015