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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Participant Flow:   Overall Study
    Ara-C + Clofarabine + Epratuzumab  
STARTED     35  
Eligible     32  
Eligible and Began Protocol Therapy     31  
COMPLETED     27  
NOT COMPLETED     8  
Death                 3  
Not protocol specified                 1  
Ineligible                 3  
Did not begin protocol therapy                 1  



  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) ]

Measure Type Primary
Measure Title Complete Remission
Measure Description Complete remission (CR) is defined as: <5% marrow aspirate blasts. Blasts can be >=5% if the blasts are found to be myeloid and there is no evidence of lymphoblasts by flow cytometry or immunostaining. Neutrophils >= 1000/mcl; platelets >100,000/mcl; and no blasts in the peripheral blood. C1 Extramedullary disease status as defined in the protocol. Complete remission with incomplete platelet recovery (CRi) is same as CR but platelet count may be <=100,000/mcl and/or ANC may be <1,000/mcl.
Time Frame After induction therapy was completed (1 or 2 months)  
Safety Issue No  

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.

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.

Measured Values
    Ara-C + Clofarabine + Epratuzumab  
Number of Participants Analyzed  
[units: participants]
  31  
Complete Remission  
[units: percentage¬†of¬†participants]
Number ( 95% Confidence Interval )
  52  
  ( 33 to 70 )  

No statistical analysis provided for Complete Remission



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

Measure Type Secondary
Measure Title Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Measure Description Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Time Frame Up to 5 years  
Safety Issue Yes  

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 received any treatment and were assessed for toxicity were included in the adverse event summaries.

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.

Measured Values
    Ara-C + Clofarabine + Epratuzumab  
Number of Participants Analyzed  
[units: participants]
  31  
Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events  
[units: Participants]
 
Abdominal pain     1  
Acute kidney injury     1  
Alanine aminotransferase increased     5  
Alkaline phosphatase increased     1  
Anemia     6  
Anorexia     1  
Aspartate aminotransferase increased     6  
Cardiac arrest     2  
Catheter related infection     2  
Diarrhea     2  
Electrocardiogram QT corrected interval prolonged     1  
Encephalopathy     2  
Enterocolitis infectious     2  
Febrile neutropenia     17  
Gum infection     1  
Hepatic failure     1  
Hypercalcemia     1  
Hyperglycemia     1  
Hyperkalemia     1  
Hypertension     1  
Hypocalcemia     1  
Hypokalemia     1  
Hyponatremia     1  
Hypophosphatemia     1  
Hypotension     2  
Hypoxia     2  
Infections and infestations-Gram neg. bacteremia     1  
Investigations - Bacteremia     1  
Leukocytosis     1  
Lung infection     4  
Lymphocyte count decreased     4  
Nervous system disorders - subdural hematoma     1  
Neutrophil count decreased     9  
Oral pain     1  
Platelet count decreased     12  
Respiratory failure     1  
Sepsis     4  
Tooth infection     1  
Tumor lysis syndrome     1  
Typhlitis     2  
White blood cell decreased     8  

No statistical analysis provided for Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events




  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
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