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S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

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: NCT00551460
Recruitment Status : Completed
First Posted : October 31, 2007
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
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 Drug: arsenic trioxide
Drug: gemtuzumab ozogamicin
Drug: mercaptopurine
Drug: methotrexate
Drug: tretinoin
Enrollment 78
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ATRA + GO + Arsenic
Hide Arm/Group Description

Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR

Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest

Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3

Consolidation 5 and 6: GO 9mg/m2 IV D1

Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year

Period Title: Overall Study
Started 78
Completed 60
Not Completed 18
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Physician Decision             1
Death             7
Ineligible             4
Not analyzable (did not start treatment)             4
Arm/Group Title ATRA + GO + Arsenic
Hide Arm/Group Description Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
Baseline Participants includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 70 participants
46.5
(19.2 to 86.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
37
  52.9%
Male
33
  47.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.4%
Native Hawaiian or Other Pacific Islander
1
   1.4%
Black or African American
7
  10.0%
White
58
  82.9%
More than one race
0
   0.0%
Unknown or Not Reported
3
   4.3%
1.Primary Outcome
Title Continuous Complete Remission at 3 Years
Hide Description Binary variable: yes if the patient achieves complete remission and remains in continuous complete remission until at least 3 years after entering the study; otherwise no.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.
Arm/Group Title ATRA + GO + Arsenic
Hide Arm/Group Description:
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74
(62 to 84)
2.Primary Outcome
Title Mortality Rate at 6 Weeks
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.
Arm/Group Title ATRA + GO + Arsenic
Hide Arm/Group Description:
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11
(5 to 21)
3.Secondary Outcome
Title Frequency of Toxicities
Hide Description Adverse events that were possibly, probably or definitely related to study drug are reported.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population includes eligible and analyzable patients. Ineligible patients and not analyzable patients from Participant Flow are excluded.
Arm/Group Title ATRA + GO + Arsenic
Hide Arm/Group Description:
Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR Consolidation 1 and 2: Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk x 5 weeks, repeat after 2 weeks rest Consolidation 2 and 3: ATRA 45 mg/m2 PO D1-7; Daunomycin 50 mg/m2/d IV D1-3 Consolidation 5 and 6: GO 9mg/m2 IV D1 Maintenance: ATRA 45 mg/m2/d PO D1-7 every 14 days; 6-MP 60 mg/m2/d PO daily for 1 year; Methotrexate 20 mg/m2 PO once/wk for 1 year
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 37
AST, SGOT 46
Acidosis (metabolic or respiratory) 4
Acute vascular leak syndrome 1
Adult respiratory distress syndrome (ARDS) 3
Albumin, serum-low (hypoalbuminemia) 24
Alkaline phosphatase 23
Alkalosis (metabolic or respiratory) 4
Allergic reaction/hypersensitivity 8
Allergic rhinitis 6
Allergy/Immunology-Other 1
Anorexia 18
Arthritis (non-septic) 1
Ascites (non-malignant) 2
Atelectasis 2
Atrioventricular block - 2nd degree Mobitz Type II 1
Atrioventricular block - first degree 1
Auditory/Ear-Other 2
Bicarbonate, serum-low 7
Bilirubin (hyperbilirubinemia) 23
Blood/Bone Marrow-Other 4
Bronchospasm, wheezing 1
Bruising (in absence of Gr 3-4 thrombocytopenia) 8
CNS cerebrovascular ischemia 4
Calcium, serum-high (hypercalcemia) 1
Calcium, serum-low (hypocalcemia) 22
Carbon monoxide diffusion capacity (DL(co)) 1
Cardiac Arrhythmia-Other 1
Cardiac General-Other 2
Cardiac troponin I (cTnI) 1
Cardiac troponin T (cTnT) 1
Cardiac-ischemia/infarction 3
Chelitis 1
Cholesterol, serum-high (hypercholesterolemia) 4
Confusion 6
Constipation 26
Cough 17
Creatinine 5
Cytokine release syndrome/acute infusion reaction 1
DIC (disseminated intravascular coagulation) 19
Dental: periodontal disease 1
Dermal change lymphedema, phlebolymphedema 1
Dermatology/Skin-Other 3
Diarrhea 23
Distention/bloating, abdominal 10
Dizziness 4
Dry mouth/salivary gland (xerostomia) 1
Dry skin 11
Dysphagia (difficulty swallowing) 3
Dyspnea (shortness of breath) 27
Edema, larynx 1
Edema: head and neck 5
Edema: limb 33
Edema: viscera 2
Encephalopathy 1
Esophagitis 2
Eyelid dysfunction 1
Fatigue (asthenia, lethargy, malaise) 34
Febrile neutropenia 29
Fever in absence of neutropenia, ANC lt1.0x10e9/L 22
Fibrinogen 13
Flatulence 2
Flushing 2
GGT (gamma-glutamyl transpeptidase) 1
Gastrointestinal-Other 1
Glomerular filtration rate 2
Glucose, serum-high (hyperglycemia) 39
Glucose, serum-low (hypoglycemia) 1
Hair loss/Alopecia (scalp or body) 6
Hearing: pts w/o audiogram not enroll monitor prgm 1
Heartburn/dyspepsia 2
Hematoma 3
Hemoglobin 41
Hemorrhage, Respiratory tract NOS 3
Hemorrhage, CNS 8
Hemorrhage, GI - Lower GI NOS 2
Hemorrhage, GI - Oral cavity 4
Hemorrhage, GI - Rectum 1
Hemorrhage, GI - Upper GI NOS 2
Hemorrhage, GU - Bladder 1
Hemorrhage, GU - Urinary NOS 10
Hemorrhage, GU - Vagina 4
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS 3
Hemorrhage, pulmonary/upper respiratory - Lung 1
Hemorrhage, pulmonary/upper respiratory - Nose 9
Hemorrhage/Bleeding-Other 8
Hemorrhoids 2
Hepatobiliary/Pancreas-Other 2
Hiccoughs (hiccups, singultus) 2
Hot flashes/flushes 1
Hypertension 25
Hypotension 4
Hypoxia 14
INR (of prothrombin time) 8
Ileus, GI (functional obstruction of bowel) 1
Incontinence, anal 1
Induration/fibrosis (skin and subcutaneous tissue) 1
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 1
Inf (clin/microbio) w/Gr 3-4 neuts - Colon 1
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth 1
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 4
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums 3
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 1
Inf (clin/microbio) w/Gr 3-4 neuts - Stomach 1
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 2
Inf w/normal ANC or Gr 1-2 neutrophils - Lung 2
Inf w/normal ANC or Gr 1-2 neutrophils - UTI 3
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway 1
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina 2
Inf w/unknown ANC - Oral cavity-gums (gingivitis) 1
Infection (documented clinically or microbiologica 1
Infection with unknown ANC - Blood 2
Infection with unknown ANC - Lung (pneumonia) 5
Infection-Other 1
Injection site reaction/extravasation changes 3
Insomnia 19
Leak (including anastomotic), GU - Bladder 1
Left ventricular systolic dysfunction 3
Leukocytes (total WBC) 26
Liver dysfunction/failure (clinical) 1
Lymphopenia 19
Magnesium, serum-high (hypermagnesemia) 16
Magnesium, serum-low (hypomagnesemia) 8
Mental status 1
Metabolic/Laboratory-Other 8
Mood alteration - agitation 3
Mood alteration - anxiety 14
Mood alteration - depression 10
Mucositis/stomatitis (clinical exam) - Oral cavity 2
Mucositis/stomatitis (functional/symp) - Oral cav 6
Muscle weakness, not d/t neuropathy - Extrem-lower 1
Muscle weakness, not d/t neuropathy - body/general 9
Musculoskeletal/Soft Tissue-Other 3
Nasal cavity/paranasal sinus reactions 3
Nausea 40
Neurology-Other 2
Neuropathy: cranial - CN II Vision 1
Neuropathy: motor 4
Neuropathy: sensory 3
Neutrophils/granulocytes (ANC/AGC) 38
Obstruction, GU - Bladder 1
Ocular/Visual-Other 5
Optic disc edema 2
PTT (Partial thromboplastin time) 13
Pain - Abdomen NOS 14
Pain - Back 8
Pain - Bone 2
Pain - Buttock 1
Pain - Cardiac/heart 1
Pain - Chest/thorax NOS 9
Pain - Dental/teeth/peridontal 1
Pain - Esophagus 2
Pain - Extremity-limb 5
Pain - Eye 2
Pain - Face 1
Pain - Head/headache 44
Pain - Joint 7
Pain - Muscle 7
Pain - Neck 3
Pain - Oral cavity 2
Pain - Pleura 1
Pain - Sinus 1
Pain - Stomach 1
Pain - Throat/pharynx/larynx 8
Pain - Urethra 2
Pain-Other 6
Petechiae/purpura (hemorrhage into skin or mucosa) 15
Phosphate, serum-low (hypophosphatemia) 7
Platelets 40
Pleural effusion (non-malignant) 9
Pneumonitis/pulmonary infiltrates 3
Potassium, serum-high (hyperkalemia) 9
Potassium, serum-low (hypokalemia) 28
Prolonged QTc interval 21
Proteinuria 6
Pruritus/itching 12
Psychosis (hallucinations/delusions) 1
Pulmonary/Upper Respiratory-Other 5
Rash/desquamation 26
Renal failure 4
Renal/Genitourinary-Other 2
Retinoic acid syndrome 6
Rigors/chills 7
SVT and nodal arrhythmia - Atrial fibrillation 1
SVT and nodal arrhythmia - SVT arrhythmia NOS 1
SVT and nodal arrhythmia - Sinus arrhythmia 3
SVT and nodal arrhythmia - Sinus bradycardia 5
SVT and nodal arrhythmia - Sinus tachycardia 20
Seizure 1
Sodium, serum-high (hypernatremia) 5
Sodium, serum-low (hyponatremia) 19
Soft tissue necrosis - Extremity-lower 1
Somnolence/depressed level of consciousness 6
Speech impairment (e.g., dysphasia or aphasia) 1
Stricture/stenosis (incl anastomotic) GI - Pharynx 1
Sweating (diaphoresis) 9
Syncope (fainting) 2
Syndromes-Other 4
Taste alteration (dysgeusia) 2
Thrombosis/embolism (vascular access-related) 1
Thrombosis/thrombus/embolism 2
Thyroid function, low (hypothyroidism) 1
Triglyceride, serum-high (hypertriglyceridemia) 11
Ulceration 2
Uric acid, serum-high (hyperuricemia) 2
Urinary frequency/urgency 1
Urinary retention (including neurogenic bladder) 4
Urine color change 1
Vaginal discharge (non-infectious) 1
Ventricular arrhythmia - PVCs 1
Ventricular arrhythmia - Ventricular tachycardia 1
Vision-blurred vision 7
Vision-flashing lights/floaters 2
Vision-photophobia 4
Vitreous hemorrhage 3
Voice changes/dysarthria 1
Vomiting 33
Watery eye (epiphora, tearing) 2
Weight gain 3
Weight loss 9
Time Frame Up to 3 years
Adverse Event Reporting Description Only adverse events and serious adverse events that are possibly, probably or definitely related to study drug are reported.
 
Arm/Group Title ATRA + GO + Arsenic
Hide Arm/Group Description Induction: ATRA 45mg/m2 PO D1-CR; Gemtuzumab Ozogamicin 9 mg/m2 IV D1; Arsenic Trioxide 0.15 mg/kg/d IV 5days/wk D10-CR
All-Cause Mortality
ATRA + GO + Arsenic
Affected / at Risk (%)
Total   10/70 (14.29%) 
Show Serious Adverse Events Hide Serious Adverse Events
ATRA + GO + Arsenic
Affected / at Risk (%)
Total   11/70 (15.71%) 
Blood and lymphatic system disorders   
DIC (disseminated intravascular coagulation)  1  2/70 (2.86%) 
Hemoglobin  1  1/70 (1.43%) 
Cardiac disorders   
Cardiac General-Other  1  1/70 (1.43%) 
SVT and nodal arrhythmia - Sinus tachycardia  1  1/70 (1.43%) 
Gastrointestinal disorders   
Ileus, GI (functional obstruction of bowel)  1  1/70 (1.43%) 
Hepatobiliary disorders   
Liver dysfunction/failure (clinical)  1  1/70 (1.43%) 
Infections and infestations   
Infection with unknown ANC - Blood  1  2/70 (2.86%) 
Infection with unknown ANC - Lung (pneumonia)  1  2/70 (2.86%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  1/70 (1.43%) 
AST, SGOT  1  2/70 (2.86%) 
Bilirubin (hyperbilirubinemia)  1  1/70 (1.43%) 
Carbon monoxide diffusion capacity (DL(co))  1  1/70 (1.43%) 
Leukocytes (total WBC)  1  1/70 (1.43%) 
Neutrophils/granulocytes (ANC/AGC)  1  1/70 (1.43%) 
Platelets  1  3/70 (4.29%) 
Nervous system disorders   
CNS cerebrovascular ischemia  1  1/70 (1.43%) 
Hemorrhage, CNS  1  1/70 (1.43%) 
Somnolence/depressed level of consciousness  1  1/70 (1.43%) 
Renal and urinary disorders   
Renal/Genitourinary-Other  1  2/70 (2.86%) 
Respiratory, thoracic and mediastinal disorders   
Carbon monoxide diffusion capacity (DL(co))  1  1/70 (1.43%) 
Dyspnea (shortness of breath)  1  1/70 (1.43%) 
Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS  1  1/70 (1.43%) 
Hypoxia  1  2/70 (2.86%) 
Pneumonitis/pulmonary infiltrates  1  1/70 (1.43%) 
Pulmonary/Upper Respiratory-Other  1  1/70 (1.43%) 
Retinoic acid syndrome  1  1/70 (1.43%) 
Vascular disorders   
Hypertension  1  1/70 (1.43%) 
1
Term from vocabulary, CTCAE (3.0)
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%
ATRA + GO + Arsenic
Affected / at Risk (%)
Total   68/70 (97.14%) 
Blood and lymphatic system disorders   
Blood/Bone Marrow-Other  1  4/70 (5.71%) 
DIC (disseminated intravascular coagulation)  1  17/70 (24.29%) 
Febrile neutropenia  1  29/70 (41.43%) 
Hemoglobin  1  40/70 (57.14%) 
Cardiac disorders   
SVT and nodal arrhythmia - Sinus bradycardia  1  5/70 (7.14%) 
SVT and nodal arrhythmia - Sinus tachycardia  1  19/70 (27.14%) 
Eye disorders   
Ocular/Visual-Other  1  5/70 (7.14%) 
Vision-blurred vision  1  7/70 (10.00%) 
Vision-photophobia  1  4/70 (5.71%) 
Gastrointestinal disorders   
Constipation  1  26/70 (37.14%) 
Diarrhea  1  23/70 (32.86%) 
Distention/bloating, abdominal  1  10/70 (14.29%) 
Hemorrhage, GI - Oral cavity  1  4/70 (5.71%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  6/70 (8.57%) 
Nausea  1  40/70 (57.14%) 
Pain - Abdomen NOS  1  14/70 (20.00%) 
Vomiting  1  33/70 (47.14%) 
General disorders   
Edema: head and neck  1  5/70 (7.14%) 
Edema: limb  1  33/70 (47.14%) 
Fatigue (asthenia, lethargy, malaise)  1  34/70 (48.57%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  22/70 (31.43%) 
Pain - Chest/thorax NOS  1  9/70 (12.86%) 
Pain-Other  1  6/70 (8.57%) 
Rigors/chills  1  7/70 (10.00%) 
Syndromes-Other  1  4/70 (5.71%) 
Immune system disorders   
Allergic reaction/hypersensitivity  1  8/70 (11.43%) 
Infections and infestations   
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  4/70 (5.71%) 
Injury, poisoning and procedural complications   
Bruising (in absence of Gr 3-4 thrombocytopenia)  1  8/70 (11.43%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  36/70 (51.43%) 
AST, SGOT  1  44/70 (62.86%) 
Alkaline phosphatase  1  23/70 (32.86%) 
Bilirubin (hyperbilirubinemia)  1  22/70 (31.43%) 
Cholesterol, serum-high (hypercholesterolemia)  1  4/70 (5.71%) 
Creatinine  1  5/70 (7.14%) 
Fibrinogen  1  13/70 (18.57%) 
INR (of prothrombin time)  1  8/70 (11.43%) 
Leukocytes (total WBC)  1  25/70 (35.71%) 
Lymphopenia  1  19/70 (27.14%) 
Metabolic/Laboratory-Other  1  8/70 (11.43%) 
Neutrophils/granulocytes (ANC/AGC)  1  37/70 (52.86%) 
PTT (Partial thromboplastin time)  1  13/70 (18.57%) 
Platelets  1  37/70 (52.86%) 
Prolonged QTc interval  1  21/70 (30.00%) 
Weight loss  1  9/70 (12.86%) 
Metabolism and nutrition disorders   
Acidosis (metabolic or respiratory)  1  4/70 (5.71%) 
Albumin, serum-low (hypoalbuminemia)  1  24/70 (34.29%) 
Alkalosis (metabolic or respiratory)  1  4/70 (5.71%) 
Anorexia  1  18/70 (25.71%) 
Bicarbonate, serum-low  1  7/70 (10.00%) 
Calcium, serum-low (hypocalcemia)  1  22/70 (31.43%) 
Glucose, serum-high (hyperglycemia)  1  39/70 (55.71%) 
Magnesium, serum-high (hypermagnesemia)  1  16/70 (22.86%) 
Magnesium, serum-low (hypomagnesemia)  1  8/70 (11.43%) 
Phosphate, serum-low (hypophosphatemia)  1  7/70 (10.00%) 
Potassium, serum-high (hyperkalemia)  1  9/70 (12.86%) 
Potassium, serum-low (hypokalemia)  1  28/70 (40.00%) 
Sodium, serum-high (hypernatremia)  1  5/70 (7.14%) 
Sodium, serum-low (hyponatremia)  1  19/70 (27.14%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  11/70 (15.71%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - body/general  1  9/70 (12.86%) 
Pain - Back  1  8/70 (11.43%) 
Pain - Extremity-limb  1  5/70 (7.14%) 
Pain - Joint  1  7/70 (10.00%) 
Pain - Muscle  1  7/70 (10.00%) 
Nervous system disorders   
Dizziness  1  4/70 (5.71%) 
Hemorrhage, CNS  1  7/70 (10.00%) 
Neuropathy: motor  1  4/70 (5.71%) 
Ocular/Visual-Other  1  5/70 (7.14%) 
Pain - Head/headache  1  44/70 (62.86%) 
Somnolence/depressed level of consciousness  1  5/70 (7.14%) 
Psychiatric disorders   
Confusion  1  6/70 (8.57%) 
Insomnia  1  19/70 (27.14%) 
Mood alteration - anxiety  1  14/70 (20.00%) 
Mood alteration - depression  1  10/70 (14.29%) 
Renal and urinary disorders   
Hemorrhage, GU - Urinary NOS  1  10/70 (14.29%) 
Proteinuria  1  6/70 (8.57%) 
Renal failure  1  4/70 (5.71%) 
Urinary retention (including neurogenic bladder)  1  4/70 (5.71%) 
Reproductive system and breast disorders   
Hemorrhage, GU - Vagina  1  4/70 (5.71%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  6/70 (8.57%) 
Cough  1  17/70 (24.29%) 
Dyspnea (shortness of breath)  1  26/70 (37.14%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  9/70 (12.86%) 
Hypoxia  1  12/70 (17.14%) 
Pain - Throat/pharynx/larynx  1  8/70 (11.43%) 
Pleural effusion (non-malignant)  1  9/70 (12.86%) 
Pulmonary/Upper Respiratory-Other  1  5/70 (7.14%) 
Retinoic acid syndrome  1  5/70 (7.14%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  11/70 (15.71%) 
Hair loss/Alopecia (scalp or body)  1  6/70 (8.57%) 
Petechiae/purpura (hemorrhage into skin or mucosa)  1  15/70 (21.43%) 
Pruritus/itching  1  12/70 (17.14%) 
Rash/desquamation  1  26/70 (37.14%) 
Sweating (diaphoresis)  1  9/70 (12.86%) 
Vascular disorders   
Hemorrhage/Bleeding-Other  1  8/70 (11.43%) 
Hypertension  1  24/70 (34.29%) 
Hypotension  1  4/70 (5.71%) 
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Leukemia Committee Statistician
Organization: SWOG Statistics and Data Management Center
Phone: 2066674623
EMail: amoseley@fredhutch.org
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00551460     History of Changes
Other Study ID Numbers: S0535
S0535 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2007
First Posted: October 31, 2007
Results First Submitted: November 21, 2017
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017