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S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00492856
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : July 18, 2014
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Leukemia
Interventions Drug: mercaptopurine
Drug: methotrexate
Drug: tretinoin
Enrollment 105

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low and Intermediate Risk APL Patients Post-consolidation ATRA, 6-MP, MTX Post-consolidation Observation Post-consolidation Gemtuzumab Ozogamicin
Hide Arm/Group Description All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX. Patients who achieved CRm after consolidation and were randomized to the observation arm. Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does).
Period Title: Induction
Started 105 0 0 0
Completed 99 0 0 0
Not Completed 6 0 0 0
Reason Not Completed
Adverse Event             2             0             0             0
Withdrawal by Subject             1             0             0             0
Death             3             0             0             0
Period Title: Consolidation
Started 92 [1] 0 0 0
Completed 83 0 0 0
Not Completed 9 0 0 0
Reason Not Completed
Adverse Event             6             0             0             0
Not protocol specified             2             0             0             0
Lost to Follow-up             1             0             0             0
[1]
Patients in CR (CRm), CRi, or PR after induction, register for consolidation and are eligible.
Period Title: Post-consolidation
Started 0 [1] 41 27 1
Completed 0 29 0 0
Not Completed 0 12 27 1
Reason Not Completed
Adverse Event             0             4             0             1
Withdrawal by Subject             0             4             0             0
Death             0             1             0             0
Not protocol specified             0             1             0             0
Lost to Follow-up             0             2             0             0
Observation Arm             0             0             27             0
[1]
Patients who achieve CRm, are randomized to the treatment arm, and are eligible.
Arm/Group Title Low and Intermediate Risk APL Patients
Hide Arm/Group Description All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
Overall Number of Baseline Participants 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 105 participants
49
(21 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
44
  41.9%
Male
61
  58.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
American Indian or Alaska Native
1
   1.0%
Asian
7
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
   7.6%
White
87
  82.9%
More than one race
0
   0.0%
Unknown or Not Reported
2
   1.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Hispanic or Latino
6
   5.7%
Not Hispanic or Latino
87
  82.9%
Unknown or Not Reported
12
  11.4%
1.Primary Outcome
Title 3-year Disease-free Survival (DFS) Rate
Hide Description DFS measured from date of post-consolidation randomization until relapse of any kind or death from any cause. Observation censored at date of last follow-up for patients last known to be alive without report of relapse. Relapse from CR/CRi is occurrence of marrow blasts ≥ 5% or presence of Auer rods or presence of neoplastic promyelocytes; (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from PR is sum of marrow blasts and promyelocytes ≥ 20%, or sum of marrow blasts and promyelocytes 6-19% with Auer rods and/or neoplastic promyelocytes; or (re)appearance of leukemic blasts or neoplastic promyelocytes in the peripheral blood; or (re)appearance of extramedullary disease. Relapse from CRc is reappearance of t(15;17) in cytogenetic analysis. Relapse from CRm/PRm is reappearance of PML-RARα by RT-PCR as defined by a normalized quotient > 10^-5 based on RT-PCR performed at appropriate central lab.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients in molecular remission after receiving consolidation and randomized to either maintenance chemotherapy or observation. As of 8/15/10, all eligible patients were non-randomly assigned to receive maintenance chemotherapy. Only those that were randomized to either maintenance treatment or observation were included.
Arm/Group Title Post-consolidation Therapy Arm I Post-consolidation Therapy Arm II
Hide Arm/Group Description:

Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.

mercaptopurine: Given orally

methotrexate: Given orally

tretinoin: Given orally

Patients receive no further chemotherapy. (Randomization and observation arm closed as of 05/27/10)
Overall Number of Participants Analyzed 28 27
Measure Type: Number
Unit of Measure: percentage of patients
96 100
2.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide Description Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. Only adverse events that are possibly, probably, or definitely related to study drug are reported.
Time Frame Up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
Arm/Group Title ATRA + Ara-C + Daunorubicin Consolidation ATRA+6-MP+MTX Gemtuzumab Ozogamicin
Hide Arm/Group Description:
ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
Overall Number of Participants Analyzed 105 90 38 1
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 5 3 2 0
AST, SGOT 2 2 1 0
Acidosis (metabolic or respiratory) 1 0 0 0
Albumin, serum-low (hypoalbuminemia) 4 0 0 0
Alkaline phosphatase 1 0 0 0
Alkalosis (metabolic or respiratory) 2 0 0 0
Anorexia 4 1 0 0
Bilirubin (hyperbilirubinemia) 7 0 1 0
CPK (creatine phosphokinase) 2 0 0 0
Calcium, serum-low (hypocalcemia) 3 1 0 0
Cardiac Arrhythmia-Other (Specify) 1 0 0 0
Cardiac troponin T (cTnT) 2 0 0 0
Cholesterol, serum-high (hypercholesterolemia) 1 0 0 0
Coagulation-Other (Specify) 2 0 0 0
Confusion 4 0 0 0
Creatinine 2 0 0 0
DIC (disseminated intravascular coagulation) 11 0 0 0
Dehydration 0 1 0 0
Diarrhea 11 0 0 0
Distention/bloating, abdominal 2 0 0 0
Dizziness 1 0 0 0
Dry skin 1 0 0 0
Dysphagia (difficulty swallowing) 0 1 0 0
Dyspnea (shortness of breath) 11 0 0 0
Enteritis (inflammation of the small bowel) 1 0 0 0
Extremity-lower (gait/walking) 1 0 0 0
Fatigue (asthenia, lethargy, malaise) 8 5 1 0
Febrile neutropenia 58 8 0 1
Fever in absence of neutropenia, ANC lt1.0x10e9/L 1 1 0 0
Flu-like syndrome 0 1 0 0
Glucose, serum-high (hyperglycemia) 4 5 0 0
Hemoglobin 37 4 3 0
Hemorrhage, CNS 1 0 0 0
Hemorrhage, GI - Rectum 1 0 0 0
Hemorrhage, GU - Vagina 1 0 0 0
Hemorrhage, pulmonary/upper respiratory - Lung 1 0 0 0
Hemorrhage, pulmonary/upper respiratory - Nose 2 0 0 0
Hypertension 3 1 0 0
Hypotension 1 2 0 0
Hypoxia 6 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Blood 10 1 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Cecum 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Colon 4 0 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Dental-tooth 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Lung 8 0 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Sinus 0 0 1 0
Inf (clin/microbio) w/Gr 3-4 neuts - Skin 3 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - UTI 1 0 0 0
Inf (clin/microbio) w/Gr 3-4 neuts - Up aerodigest 1 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder 0 0 1 0
Inf w/normal ANC or Gr 1-2 neutrophils - Blood 1 5 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Catheter 0 1 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Gallbladd 1 0 0 0
Inf w/normal ANC or Gr 1-2 neutrophils - Skin 3 1 0 0
Inf w/unknown ANC - Oral cavity-gums (gingivitis) 1 0 0 0
Infection with unknown ANC - Bladder (urinary) 1 0 0 0
Infection with unknown ANC - Lung (pneumonia) 1 0 0 0
Infection with unknown ANC - Rectum 1 0 0 0
Infection with unknown ANC - Skin (cellulitis) 1 0 0 0
Infection-Other (Specify) 2 0 0 0
Left ventricular systolic dysfunction 0 3 3 0
Leukocytes (total WBC) 34 37 3 0
Lymphopenia 20 20 7 0
Metabolic/Laboratory-Other (Specify) 1 0 0 0
Mood alteration - agitation 1 0 0 0
Mood alteration - anxiety 0 1 0 0
Mood alteration - depression 1 0 0 0
Mucositis/stomatitis (clinical exam) - Oral cavity 3 0 1 0
Mucositis/stomatitis (clinical exam) - Rectum 1 0 0 0
Mucositis/stomatitis (functional/symp) - Oral cav 0 1 0 0
Muscle weakness, not d/t neuropathy - Extrem-lower 1 0 0 0
Muscle weakness, not d/t neuropathy - Extrem-upper 1 0 0 0
Muscle weakness, not d/t neuropathy - body/general 2 0 0 0
Myositis (inflammation/damage of muscle) 2 0 0 0
Nausea 6 4 1 0
Neuropathy: motor 1 0 0 0
Neuropathy: sensory 0 2 0 0
Neutrophils/granulocytes (ANC/AGC) 34 55 4 0
Opportunistic inf associated w/gt=Gr 2 lymphopenia 0 1 0 0
Pain - Abdomen NOS 3 1 0 0
Pain - Back 2 0 0 0
Pain - Chest/thorax NOS 0 2 0 0
Pain - Extremity-limb 1 1 0 0
Pain - Head/headache 10 3 6 0
Pain - Joint 0 4 0 0
Pain - Muscle 3 2 0 0
Pain - Neck 1 0 0 0
Pain - Rectum 0 1 0 0
Pain - Scrotum 1 0 0 0
Pain - Throat/pharynx/larynx 0 1 0 0
Pericardial effusion (non-malignant) 1 1 0 0
Pericarditis 0 1 0 0
Petechiae/purpura (hemorrhage into skin or mucosa) 2 0 0 0
Phosphate, serum-low (hypophosphatemia) 7 1 0 0
Photosensitivity 1 0 0 0
Platelets 42 18 2 0
Pleural effusion (non-malignant) 1 0 0 0
Pneumonitis/pulmonary infiltrates 0 1 0 0
Potassium, serum-low (hypokalemia) 4 0 0 0
Prolonged QTc interval 3 6 0 0
Pruritus/itching 0 0 1 0
Rash/desquamation 3 1 0 0
Renal failure 7 1 0 0
Renal/Genitourinary-Other (Specify) 1 0 0 0
Restrictive cardiomyopathy 0 1 0 0
Retinal detachment 1 0 0 0
Retinoic acid syndrome 13 0 0 0
Sodium, serum-low (hyponatremia) 4 0 0 0
Syncope (fainting) 3 0 0 0
Thrombosis/thrombus/embolism 1 0 0 0
Triglyceride, serum-high (hypertriglyceridemia) 5 2 3 0
Typhlitis (cecal inflammation) 3 0 0 0
Uric acid, serum-high (hyperuricemia) 0 1 0 0
Vasovagal episode 1 1 0 0
Ventricular arrhythmia - Ventricular tachycardia 1 1 0 0
Vomiting 1 1 0 0
Weight gain 1 0 0 0
Time Frame Up to 5 years
Adverse Event Reporting Description Eligible patients who received any treatment and were assessed for adverse events were included in the adverse event summaries.
 
Arm/Group Title ATRA + Ara-C + Daunorubicin Consolidation ATRA+6-MP+MTX Gemtuzumab Ozogamicin
Hide Arm/Group Description ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6 Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
All-Cause Mortality
ATRA + Ara-C + Daunorubicin Consolidation ATRA+6-MP+MTX Gemtuzumab Ozogamicin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ATRA + Ara-C + Daunorubicin Consolidation ATRA+6-MP+MTX Gemtuzumab Ozogamicin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/105 (7.62%)   4/90 (4.44%)   1/38 (2.63%)   0/1 (0.00%) 
Cardiac disorders         
Left ventricular systolic dysfunction  1  0/105 (0.00%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
Pericardial effusion (non-malignant)  1  1/105 (0.95%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
SVT and nodal arrhythmia - Atrial flutter  1  0/105 (0.00%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
Eye disorders         
Retinal detachment  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders         
Typhlitis (cecal inflammation)  1  2/105 (1.90%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
General disorders         
Extremity-lower (gait/walking)  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Sudden death  1  1/105 (0.95%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
Infections and infestations         
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  0/105 (0.00%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
Infection-Other  1  0/105 (0.00%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
Investigations         
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/105 (0.00%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
AST, SGOT  1  0/105 (0.00%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
Amylase  1  0/105 (0.00%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
CPK (creatine phosphokinase)  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders         
Acidosis (metabolic or respiratory)  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle weakness, not d/t neuropathy - body/general  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Myositis (inflammation/damage of muscle)  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Pain - Muscle  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders         
Renal failure  1  1/105 (0.95%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnea (shortness of breath)  1  0/105 (0.00%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Lung  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Pneumonitis/pulmonary infiltrates  1  0/105 (0.00%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
Vascular disorders         
Hypotension  1  0/105 (0.00%)  1/90 (1.11%)  1/38 (2.63%)  0/1 (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%
ATRA + Ara-C + Daunorubicin Consolidation ATRA+6-MP+MTX Gemtuzumab Ozogamicin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   105/105 (100.00%)   89/90 (98.89%)   37/38 (97.37%)   1/1 (100.00%) 
Blood and lymphatic system disorders         
DIC (disseminated intravascular coagulation)  1  24/105 (22.86%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
Febrile neutropenia  1  62/105 (59.05%)  8/90 (8.89%)  0/38 (0.00%)  1/1 (100.00%) 
Hemoglobin  1  43/105 (40.95%)  59/90 (65.56%)  22/38 (57.89%)  0/1 (0.00%) 
Cardiac disorders         
Left ventricular systolic dysfunction  1  4/105 (3.81%)  7/90 (7.78%)  3/38 (7.89%)  0/1 (0.00%) 
SVT and nodal arrhythmia - Atrial fibrillation  1  3/105 (2.86%)  2/90 (2.22%)  2/38 (5.26%)  0/1 (0.00%) 
SVT and nodal arrhythmia - Sinus tachycardia  1  13/105 (12.38%)  10/90 (11.11%)  0/38 (0.00%)  0/1 (0.00%) 
Ventricular arrhythmia - Ventricular tachycardia  1  5/105 (4.76%)  6/90 (6.67%)  0/38 (0.00%)  0/1 (0.00%) 
Eye disorders         
Ocular/Visual-Other  1  4/105 (3.81%)  5/90 (5.56%)  1/38 (2.63%)  0/1 (0.00%) 
Vision-blurred vision  1  6/105 (5.71%)  7/90 (7.78%)  2/38 (5.26%)  0/1 (0.00%) 
Vision-photophobia  1  0/105 (0.00%)  0/90 (0.00%)  2/38 (5.26%)  0/1 (0.00%) 
Watery eye (epiphora, tearing)  1  1/105 (0.95%)  5/90 (5.56%)  0/38 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders         
Chelitis  1  5/105 (4.76%)  0/90 (0.00%)  3/38 (7.89%)  0/1 (0.00%) 
Constipation  1  20/105 (19.05%)  22/90 (24.44%)  4/38 (10.53%)  0/1 (0.00%) 
Diarrhea  1  77/105 (73.33%)  35/90 (38.89%)  11/38 (28.95%)  0/1 (0.00%) 
Dysphagia (difficulty swallowing)  1  6/105 (5.71%)  4/90 (4.44%)  2/38 (5.26%)  0/1 (0.00%) 
Heartburn/dyspepsia  1  11/105 (10.48%)  6/90 (6.67%)  3/38 (7.89%)  0/1 (0.00%) 
Hemorrhage, GI - Oral cavity  1  6/105 (5.71%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Hemorrhoids  1  1/105 (0.95%)  2/90 (2.22%)  2/38 (5.26%)  0/1 (0.00%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  38/105 (36.19%)  14/90 (15.56%)  4/38 (10.53%)  0/1 (0.00%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  9/105 (8.57%)  2/90 (2.22%)  2/38 (5.26%)  0/1 (0.00%) 
Nausea  1  72/105 (68.57%)  66/90 (73.33%)  26/38 (68.42%)  0/1 (0.00%) 
Pain - Abdomen NOS  1  21/105 (20.00%)  7/90 (7.78%)  3/38 (7.89%)  1/1 (100.00%) 
Vomiting  1  42/105 (40.00%)  29/90 (32.22%)  6/38 (15.79%)  0/1 (0.00%) 
General disorders         
Edema: limb  1  25/105 (23.81%)  13/90 (14.44%)  4/38 (10.53%)  1/1 (100.00%) 
Fatigue (asthenia, lethargy, malaise)  1  67/105 (63.81%)  70/90 (77.78%)  27/38 (71.05%)  1/1 (100.00%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  29/105 (27.62%)  16/90 (17.78%)  3/38 (7.89%)  0/1 (0.00%) 
Pain - Chest/thorax NOS  1  8/105 (7.62%)  16/90 (17.78%)  4/38 (10.53%)  0/1 (0.00%) 
Pain-Other  1  5/105 (4.76%)  3/90 (3.33%)  1/38 (2.63%)  1/1 (100.00%) 
Rigors/chills  1  31/105 (29.52%)  13/90 (14.44%)  1/38 (2.63%)  0/1 (0.00%) 
Immune system disorders         
Allergic reaction/hypersensitivity  1  12/105 (11.43%)  2/90 (2.22%)  1/38 (2.63%)  0/1 (0.00%) 
Infections and infestations         
Inf (clin/microbio) w/Gr 3-4 neuts - Blood  1  12/105 (11.43%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Colon  1  6/105 (5.71%)  0/90 (0.00%)  1/38 (2.63%)  0/1 (0.00%) 
Inf (clin/microbio) w/Gr 3-4 neuts - Lung  1  15/105 (14.29%)  2/90 (2.22%)  1/38 (2.63%)  0/1 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  4/105 (3.81%)  10/90 (11.11%)  0/38 (0.00%)  0/1 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Lung  1  3/105 (2.86%)  3/90 (3.33%)  2/38 (5.26%)  0/1 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Pharynx  1  0/105 (0.00%)  2/90 (2.22%)  2/38 (5.26%)  0/1 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  6/105 (5.71%)  6/90 (6.67%)  2/38 (5.26%)  0/1 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Up airway  1  0/105 (0.00%)  2/90 (2.22%)  3/38 (7.89%)  0/1 (0.00%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Vagina  1  0/105 (0.00%)  1/90 (1.11%)  2/38 (5.26%)  0/1 (0.00%) 
Inf w/unknown ANC - Oral cavity-gums (gingivitis)  1  1/105 (0.95%)  0/90 (0.00%)  0/38 (0.00%)  1/1 (100.00%) 
Investigations         
ALT, SGPT (serum glutamic pyruvic transaminase)  1  47/105 (44.76%)  46/90 (51.11%)  19/38 (50.00%)  0/1 (0.00%) 
AST, SGOT  1  54/105 (51.43%)  43/90 (47.78%)  19/38 (50.00%)  0/1 (0.00%) 
Alkaline phosphatase  1  17/105 (16.19%)  27/90 (30.00%)  5/38 (13.16%)  0/1 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  37/105 (35.24%)  14/90 (15.56%)  8/38 (21.05%)  0/1 (0.00%) 
Cholesterol, serum-high (hypercholesterolemia)  1  18/105 (17.14%)  22/90 (24.44%)  11/38 (28.95%)  0/1 (0.00%) 
Creatinine  1  19/105 (18.10%)  13/90 (14.44%)  2/38 (5.26%)  0/1 (0.00%) 
Fibrinogen  1  6/105 (5.71%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
INR (of prothrombin time)  1  11/105 (10.48%)  1/90 (1.11%)  4/38 (10.53%)  0/1 (0.00%) 
Leukocytes (total WBC)  1  35/105 (33.33%)  46/90 (51.11%)  16/38 (42.11%)  0/1 (0.00%) 
Lymphopenia  1  21/105 (20.00%)  28/90 (31.11%)  13/38 (34.21%)  0/1 (0.00%) 
Metabolic/Laboratory-Other  1  14/105 (13.33%)  15/90 (16.67%)  4/38 (10.53%)  0/1 (0.00%) 
Neutrophils/granulocytes (ANC/AGC)  1  36/105 (34.29%)  61/90 (67.78%)  10/38 (26.32%)  0/1 (0.00%) 
PTT (Partial thromboplastin time)  1  16/105 (15.24%)  6/90 (6.67%)  4/38 (10.53%)  0/1 (0.00%) 
Platelets  1  44/105 (41.90%)  54/90 (60.00%)  11/38 (28.95%)  0/1 (0.00%) 
Prolonged QTc interval  1  10/105 (9.52%)  28/90 (31.11%)  0/38 (0.00%)  0/1 (0.00%) 
Weight gain  1  5/105 (4.76%)  6/90 (6.67%)  4/38 (10.53%)  0/1 (0.00%) 
Weight loss  1  15/105 (14.29%)  6/90 (6.67%)  1/38 (2.63%)  0/1 (0.00%) 
Metabolism and nutrition disorders         
Albumin, serum-low (hypoalbuminemia)  1  37/105 (35.24%)  19/90 (21.11%)  6/38 (15.79%)  0/1 (0.00%) 
Anorexia  1  45/105 (42.86%)  16/90 (17.78%)  5/38 (13.16%)  0/1 (0.00%) 
Bicarbonate, serum-low  1  7/105 (6.67%)  5/90 (5.56%)  1/38 (2.63%)  0/1 (0.00%) 
Calcium, serum-low (hypocalcemia)  1  33/105 (31.43%)  20/90 (22.22%)  5/38 (13.16%)  0/1 (0.00%) 
Dehydration  1  2/105 (1.90%)  5/90 (5.56%)  0/38 (0.00%)  0/1 (0.00%) 
Glucose, serum-high (hyperglycemia)  1  36/105 (34.29%)  40/90 (44.44%)  15/38 (39.47%)  0/1 (0.00%) 
Glucose, serum-low (hypoglycemia)  1  5/105 (4.76%)  10/90 (11.11%)  1/38 (2.63%)  0/1 (0.00%) 
Magnesium, serum-high (hypermagnesemia)  1  12/105 (11.43%)  4/90 (4.44%)  1/38 (2.63%)  0/1 (0.00%) 
Magnesium, serum-low (hypomagnesemia)  1  17/105 (16.19%)  16/90 (17.78%)  6/38 (15.79%)  0/1 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  16/105 (15.24%)  4/90 (4.44%)  0/38 (0.00%)  0/1 (0.00%) 
Potassium, serum-high (hyperkalemia)  1  3/105 (2.86%)  5/90 (5.56%)  2/38 (5.26%)  0/1 (0.00%) 
Potassium, serum-low (hypokalemia)  1  37/105 (35.24%)  19/90 (21.11%)  4/38 (10.53%)  0/1 (0.00%) 
Sodium, serum-low (hyponatremia)  1  30/105 (28.57%)  15/90 (16.67%)  6/38 (15.79%)  0/1 (0.00%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  46/105 (43.81%)  30/90 (33.33%)  18/38 (47.37%)  0/1 (0.00%) 
Uric acid, serum-high (hyperuricemia)  1  4/105 (3.81%)  7/90 (7.78%)  1/38 (2.63%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle weakness, not d/t neuropathy - body/general  1  5/105 (4.76%)  6/90 (6.67%)  1/38 (2.63%)  0/1 (0.00%) 
Pain - Back  1  10/105 (9.52%)  15/90 (16.67%)  3/38 (7.89%)  0/1 (0.00%) 
Pain - Bone  1  4/105 (3.81%)  3/90 (3.33%)  2/38 (5.26%)  0/1 (0.00%) 
Pain - Chest wall  1  4/105 (3.81%)  2/90 (2.22%)  2/38 (5.26%)  0/1 (0.00%) 
Pain - Extremity-limb  1  12/105 (11.43%)  10/90 (11.11%)  3/38 (7.89%)  0/1 (0.00%) 
Pain - Joint  1  5/105 (4.76%)  20/90 (22.22%)  6/38 (15.79%)  0/1 (0.00%) 
Pain - Muscle  1  17/105 (16.19%)  17/90 (18.89%)  7/38 (18.42%)  0/1 (0.00%) 
Pain - Neck  1  7/105 (6.67%)  3/90 (3.33%)  1/38 (2.63%)  0/1 (0.00%) 
Nervous system disorders         
Ataxia (incoordination)  1  0/105 (0.00%)  1/90 (1.11%)  2/38 (5.26%)  0/1 (0.00%) 
Dizziness  1  12/105 (11.43%)  21/90 (23.33%)  6/38 (15.79%)  0/1 (0.00%) 
Hemorrhage, CNS  1  7/105 (6.67%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Neuropathy: sensory  1  5/105 (4.76%)  35/90 (38.89%)  4/38 (10.53%)  0/1 (0.00%) 
Ocular/Visual-Other  1  4/105 (3.81%)  5/90 (5.56%)  1/38 (2.63%)  0/1 (0.00%) 
Pain - Head/headache  1  60/105 (57.14%)  54/90 (60.00%)  20/38 (52.63%)  0/1 (0.00%) 
Taste alteration (dysgeusia)  1  4/105 (3.81%)  10/90 (11.11%)  3/38 (7.89%)  0/1 (0.00%) 
Tremor  1  2/105 (1.90%)  5/90 (5.56%)  1/38 (2.63%)  0/1 (0.00%) 
Psychiatric disorders         
Confusion  1  14/105 (13.33%)  2/90 (2.22%)  0/38 (0.00%)  0/1 (0.00%) 
Insomnia  1  18/105 (17.14%)  17/90 (18.89%)  6/38 (15.79%)  1/1 (100.00%) 
Mood alteration - anxiety  1  15/105 (14.29%)  11/90 (12.22%)  5/38 (13.16%)  0/1 (0.00%) 
Mood alteration - depression  1  14/105 (13.33%)  4/90 (4.44%)  4/38 (10.53%)  0/1 (0.00%) 
Renal and urinary disorders         
Renal failure  1  8/105 (7.62%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
Urinary frequency/urgency  1  4/105 (3.81%)  8/90 (8.89%)  2/38 (5.26%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis  1  4/105 (3.81%)  18/90 (20.00%)  4/38 (10.53%)  0/1 (0.00%) 
Cough  1  19/105 (18.10%)  24/90 (26.67%)  11/38 (28.95%)  0/1 (0.00%) 
Dyspnea (shortness of breath)  1  39/105 (37.14%)  22/90 (24.44%)  6/38 (15.79%)  0/1 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Lung  1  6/105 (5.71%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Hemorrhage, pulmonary/upper respiratory - Nose  1  16/105 (15.24%)  1/90 (1.11%)  4/38 (10.53%)  0/1 (0.00%) 
Hypoxia  1  11/105 (10.48%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Pain - Throat/pharynx/larynx  1  2/105 (1.90%)  11/90 (12.22%)  3/38 (7.89%)  0/1 (0.00%) 
Pleural effusion (non-malignant)  1  11/105 (10.48%)  3/90 (3.33%)  0/38 (0.00%)  0/1 (0.00%) 
Pulmonary/Upper Respiratory-Other  1  5/105 (4.76%)  5/90 (5.56%)  1/38 (2.63%)  0/1 (0.00%) 
Retinoic acid syndrome  1  24/105 (22.86%)  0/90 (0.00%)  0/38 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatology/Skin-Other  1  7/105 (6.67%)  12/90 (13.33%)  4/38 (10.53%)  0/1 (0.00%) 
Dry skin  1  20/105 (19.05%)  23/90 (25.56%)  10/38 (26.32%)  0/1 (0.00%) 
Hair loss/Alopecia (scalp or body)  1  36/105 (34.29%)  28/90 (31.11%)  5/38 (13.16%)  0/1 (0.00%) 
Nail changes  1  0/105 (0.00%)  6/90 (6.67%)  2/38 (5.26%)  0/1 (0.00%) 
Petechiae/purpura (hemorrhage into skin or mucosa)  1  15/105 (14.29%)  1/90 (1.11%)  0/38 (0.00%)  0/1 (0.00%) 
Pruritus/itching  1  22/105 (20.95%)  15/90 (16.67%)  5/38 (13.16%)  1/1 (100.00%) 
Rash/desquamation  1  53/105 (50.48%)  32/90 (35.56%)  12/38 (31.58%)  0/1 (0.00%) 
Sweating (diaphoresis)  1  16/105 (15.24%)  5/90 (5.56%)  3/38 (7.89%)  0/1 (0.00%) 
Vascular disorders         
Hemorrhage/Bleeding-Other  1  6/105 (5.71%)  2/90 (2.22%)  1/38 (2.63%)  0/1 (0.00%) 
Hypertension  1  21/105 (20.00%)  5/90 (5.56%)  3/38 (7.89%)  0/1 (0.00%) 
Hypotension  1  14/105 (13.33%)  6/90 (6.67%)  2/38 (5.26%)  0/1 (0.00%) 
Thrombosis/thrombus/embolism  1  9/105 (8.57%)  5/90 (5.56%)  0/38 (0.00%)  0/1 (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
Name/Title: SWOG Leukemia Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4408
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00492856     History of Changes
Other Study ID Numbers: S0521
S0521 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: June 25, 2007
First Posted: June 27, 2007
Results First Submitted: April 22, 2014
Results First Posted: July 18, 2014
Last Update Posted: May 17, 2016