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) ]
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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 ]


  Serious Adverse Events


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

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Ara-C + Clofarabine + Epratuzumab  
Total, other (not including serious) adverse events    
# participants affected / at risk     27/31  
Blood and lymphatic system disorders    
Anemia † 1  
# participants affected / at risk     10/31 (32.26%)  
Febrile neutropenia † 1  
# participants affected / at risk     13/31 (41.94%)  
Cardiac disorders    
Sinus tachycardia † 1  
# participants affected / at risk     5/31 (16.13%)  
Ear and labyrinth disorders    
Ear pain † 1  
# participants affected / at risk     2/31 (6.45%)  
Eye disorders    
Blurred vision † 1  
# participants affected / at risk     2/31 (6.45%)  
Eye disorders - Other, specify † 1  
# participants affected / at risk     2/31 (6.45%)  
Gastrointestinal disorders    
Abdominal pain † 1  
# participants affected / at risk     5/31 (16.13%)  
Constipation † 1  
# participants affected / at risk     4/31 (12.90%)  
Diarrhea † 1  
# participants affected / at risk     13/31 (41.94%)  
Dysphagia † 1  
# participants affected / at risk     3/31 (9.68%)  
Mucositis oral † 1  
# participants affected / at risk     8/31 (25.81%)  
Nausea † 1  
# participants affected / at risk     19/31 (61.29%)  
Vomiting † 1  
# participants affected / at risk     12/31 (38.71%)  
General disorders    
Chills † 1  
# participants affected / at risk     5/31 (16.13%)  
Edema limbs † 1  
# participants affected / at risk     4/31 (12.90%)  
Fatigue † 1  
# participants affected / at risk     12/31 (38.71%)  
Fever † 1  
# participants affected / at risk     4/31 (12.90%)  
Injection site reaction † 1  
# participants affected / at risk     2/31 (6.45%)  
Localized edema † 1  
# participants affected / at risk     2/31 (6.45%)  
Infections and infestations    
Catheter related infection † 1  
# participants affected / at risk     2/31 (6.45%)  
Enterocolitis infectious † 1  
# participants affected / at risk     2/31 (6.45%)  
Gum infection † 1  
# participants affected / at risk     3/31 (9.68%)  
Lung infection † 1  
# participants affected / at risk     2/31 (6.45%)  
Papulopustular rash † 1  
# participants affected / at risk     2/31 (6.45%)  
Sepsis † 1  
# participants affected / at risk     4/31 (12.90%)  
Investigations    
Activated partial thromboplastin time prolonged † 1  
# participants affected / at risk     3/31 (9.68%)  
Alanine aminotransferase increased † 1  
# participants affected / at risk     10/31 (32.26%)  
Alkaline phosphatase increased † 1  
# participants affected / at risk     11/31 (35.48%)  
Aspartate aminotransferase increased † 1  
# participants affected / at risk     12/31 (38.71%)  
Blood bilirubin increased † 1  
# participants affected / at risk     3/31 (9.68%)  
Creatinine increased † 1  
# participants affected / at risk     2/31 (6.45%)  
INR increased † 1  
# participants affected / at risk     2/31 (6.45%)  
Lymphocyte count decreased † 1  
# participants affected / at risk     5/31 (16.13%)  
Neutrophil count decreased † 1  
# participants affected / at risk     10/31 (32.26%)  
Platelet count decreased † 1  
# participants affected / at risk     15/31 (48.39%)  
Weight loss † 1  
# participants affected / at risk     4/31 (12.90%)  
White blood cell decreased † 1  
# participants affected / at risk     9/31 (29.03%)  
Metabolism and nutrition disorders    
Anorexia † 1  
# participants affected / at risk     4/31 (12.90%)  
Hyperglycemia † 1  
# participants affected / at risk     14/31 (45.16%)  
Hyperkalemia † 1  
# participants affected / at risk     3/31 (9.68%)  
Hypermagnesemia † 1  
# participants affected / at risk     3/31 (9.68%)  
Hypernatremia † 1  
# participants affected / at risk     2/31 (6.45%)  
Hypoalbuminemia † 1  
# participants affected / at risk     12/31 (38.71%)  
Hypocalcemia † 1  
# participants affected / at risk     11/31 (35.48%)  
Hypoglycemia † 1  
# participants affected / at risk     4/31 (12.90%)  
Hypokalemia † 1  
# participants affected / at risk     8/31 (25.81%)  
Hypomagnesemia † 1  
# participants affected / at risk     6/31 (19.35%)  
Hyponatremia † 1  
# participants affected / at risk     5/31 (16.13%)  
Musculoskeletal and connective tissue disorders    
Back pain † 1  
# participants affected / at risk     2/31 (6.45%)  
Chest wall pain † 1  
# participants affected / at risk     2/31 (6.45%)  
Generalized muscle weakness † 1  
# participants affected / at risk     2/31 (6.45%)  
Pain in extremity † 1  
# participants affected / at risk     5/31 (16.13%)  
Nervous system disorders    
Dizziness † 1  
# participants affected / at risk     3/31 (9.68%)  
Headache † 1  
# participants affected / at risk     8/31 (25.81%)  
Peripheral sensory neuropathy † 1  
# participants affected / at risk     4/31 (12.90%)  
Psychiatric disorders    
Anxiety † 1  
# participants affected / at risk     2/31 (6.45%)  
Depression † 1  
# participants affected / at risk     2/31 (6.45%)  
Hallucinations † 1  
# participants affected / at risk     2/31 (6.45%)  
Insomnia † 1  
# participants affected / at risk     5/31 (16.13%)  
Respiratory, thoracic and mediastinal disorders    
Cough † 1  
# participants affected / at risk     6/31 (19.35%)  
Dyspnea † 1  
# participants affected / at risk     3/31 (9.68%)  
Epistaxis † 1  
# participants affected / at risk     3/31 (9.68%)  
Sore throat † 1  
# participants affected / at risk     6/31 (19.35%)  
Skin and subcutaneous tissue disorders    
Dry skin † 1  
# participants affected / at risk     5/31 (16.13%)  
Palmar-plantar erythrodysesthesia syndrome † 1  
# participants affected / at risk     2/31 (6.45%)  
Pruritus † 1  
# participants affected / at risk     7/31 (22.58%)  
Purpura † 1  
# participants affected / at risk     2/31 (6.45%)  
Rash acneiform † 1  
# participants affected / at risk     2/31 (6.45%)  
Rash maculo-papular † 1  
# participants affected / at risk     12/31 (38.71%)  
Skin and subcutaneous tissue disorders - Other † 1  
# participants affected / at risk     2/31 (6.45%)  
Skin ulceration † 1  
# participants affected / at risk     2/31 (6.45%)  
Vascular disorders    
Hematoma † 1  
# participants affected / at risk     3/31 (9.68%)  
Hypertension † 1  
# participants affected / at risk     6/31 (19.35%)  
Hypotension † 1  
# participants affected / at risk     2/31 (6.45%)  
Events were collected by systematic assessment
1 Term from vocabulary, "



  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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