S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00945815
First received: July 23, 2009
Last updated: November 13, 2013
Last verified: November 2013
Results First Received: November 13, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Biological: epratuzumab
Drug: clofarabine
Drug: cytarabine
Other: laboratory biomarker analysis

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible patients who began protocol therapy were included in this analysis.

Reporting Groups
  Description
Ara-C + Clofarabine + Epratuzumab Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.

Baseline Measures
    Ara-C + Clofarabine + Epratuzumab  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Median ( Full Range )
  41  
  ( 21 to 69 )  
Gender  
[units: participants]
 
Female     8  
Male     23  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     11  
Not Hispanic or Latino     18  
Unknown or Not Reported     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     26  
More than one race     0  
Unknown or Not Reported     3  



  Outcome Measures
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1.  Primary:   Complete Remission   [ Time Frame: After induction therapy was completed (1 or 2 months) ]

2.  Secondary:   Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events   [ Time Frame: Up to 5 years ]


  Serious Adverse Events
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Time Frame Up to 5 years
Additional Description No text entered.

Reporting Groups
  Description
Ara-C + Clofarabine + Epratuzumab Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.

Serious Adverse Events
    Ara-C + Clofarabine + Epratuzumab  
Total, serious adverse events    
# participants affected / at risk     15/31 (48.39%)  
Blood and lymphatic system disorders    
Anemia † 1  
# participants affected / at risk     1/31 (3.23%)  
Febrile neutropenia † 1  
# participants affected / at risk     6/31 (19.35%)  
Cardiac disorders    
Cardiac arrest † 1  
# participants affected / at risk     2/31 (6.45%)  
Gastrointestinal disorders    
Abdominal pain † 1  
# participants affected / at risk     1/31 (3.23%)  
Diarrhea † 1  
# participants affected / at risk     2/31 (6.45%)  
Oral pain † 1  
# participants affected / at risk     1/31 (3.23%)  
Typhlitis † 1  
# participants affected / at risk     1/31 (3.23%)  
General disorders    
Death NOS † 1  
# participants affected / at risk     1/31 (3.23%)  
Hepatobiliary disorders    
Hepatic failure † 1  
# participants affected / at risk     1/31 (3.23%)  
Infections and infestations    
Catheter related infection † 1  
# participants affected / at risk     3/31 (9.68%)  
Enterocolitis infectious † 1  
# participants affected / at risk     1/31 (3.23%)  
Lung infection † 1  
# participants affected / at risk     3/31 (9.68%)  
Sepsis † 1  
# participants affected / at risk     4/31 (12.90%)  
Tooth infection † 1  
# participants affected / at risk     1/31 (3.23%)  
Investigations    
Alanine aminotransferase increased † 1  
# participants affected / at risk     2/31 (6.45%)  
Aspartate aminotransferase increased † 1  
# participants affected / at risk     2/31 (6.45%)  
Investigations - Other, specify † 1  
# participants affected / at risk     1/31 (3.23%)  
Neutrophil count decreased † 1  
# participants affected / at risk     1/31 (3.23%)  
Platelet count decreased † 1  
# participants affected / at risk     2/31 (6.45%)  
Metabolism and nutrition disorders    
Hypocalcemia † 1  
# participants affected / at risk     1/31 (3.23%)  
Hypokalemia † 1  
# participants affected / at risk     1/31 (3.23%)  
Hyponatremia † 1  
# participants affected / at risk     1/31 (3.23%)  
Hypophosphatemia † 1  
# participants affected / at risk     1/31 (3.23%)  
Nervous system disorders    
Encephalopathy † 1  
# participants affected / at risk     2/31 (6.45%)  
Nervous system disorders - Other, specify † 1  
# participants affected / at risk     1/31 (3.23%)  
Transient ischemic attacks † 1  
# participants affected / at risk     1/31 (3.23%)  
Renal and urinary disorders    
Acute kidney injury † 1  
# participants affected / at risk     1/31 (3.23%)  
Respiratory, thoracic and mediastinal disorders    
Hypoxia † 1  
# participants affected / at risk     1/31 (3.23%)  
Respiratory failure † 1  
# participants affected / at risk     2/31 (6.45%)  
Vascular disorders    
Hypotension † 1  
# participants affected / at risk     1/31 (3.23%)  
Events were collected by systematic assessment
1 Term from vocabulary, "




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


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