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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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00945815
First received: July 23, 2009
Last updated: April 14, 2016
Last verified: April 2016
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
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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 
Overall Participants Analyzed 
[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 †   
# participants affected / at risk   1/31 (3.23%) 
Febrile neutropenia †   
# participants affected / at risk   6/31 (19.35%) 
Cardiac disorders   
Cardiac arrest †   
# participants affected / at risk   2/31 (6.45%) 
Gastrointestinal disorders   
Abdominal pain †   
# participants affected / at risk   1/31 (3.23%) 
Diarrhea †   
# participants affected / at risk   2/31 (6.45%) 
Oral pain †   
# participants affected / at risk   1/31 (3.23%) 
Typhlitis †   
# participants affected / at risk   1/31 (3.23%) 
General disorders   
Death NOS †   
# participants affected / at risk   1/31 (3.23%) 
Hepatobiliary disorders   
Hepatic failure †   
# participants affected / at risk   1/31 (3.23%) 
Infections and infestations   
Catheter related infection †   
# participants affected / at risk   3/31 (9.68%) 
Enterocolitis infectious †   
# participants affected / at risk   1/31 (3.23%) 
Lung infection †   
# participants affected / at risk   3/31 (9.68%) 
Sepsis †   
# participants affected / at risk   4/31 (12.90%) 
Tooth infection †   
# participants affected / at risk   1/31 (3.23%) 
Investigations   
Alanine aminotransferase increased †   
# participants affected / at risk   2/31 (6.45%) 
Aspartate aminotransferase increased †   
# participants affected / at risk   2/31 (6.45%) 
Investigations - Other, specify †   
# participants affected / at risk   1/31 (3.23%) 
Neutrophil count decreased †   
# participants affected / at risk   1/31 (3.23%) 
Platelet count decreased †   
# participants affected / at risk   2/31 (6.45%) 
Metabolism and nutrition disorders   
Hypocalcemia †   
# participants affected / at risk   1/31 (3.23%) 
Hypokalemia †   
# participants affected / at risk   1/31 (3.23%) 
Hyponatremia †   
# participants affected / at risk   1/31 (3.23%) 
Hypophosphatemia †   
# participants affected / at risk   1/31 (3.23%) 
Nervous system disorders   
Encephalopathy †   
# participants affected / at risk   2/31 (6.45%) 
Nervous system disorders - Other, specify †   
# participants affected / at risk   1/31 (3.23%) 
Transient ischemic attacks †   
# participants affected / at risk   1/31 (3.23%) 
Renal and urinary disorders   
Acute kidney injury †   
# participants affected / at risk   1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia †   
# participants affected / at risk   1/31 (3.23%) 
Respiratory failure †   
# participants affected / at risk   2/31 (6.45%) 
Vascular disorders   
Hypotension †   
# participants affected / at risk   1/31 (3.23%) 
Events were collected by systematic assessment




  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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