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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:
ClinicalTrials.gov Identifier:
NCT00945815
First Posted: July 24, 2009
Last Update Posted: May 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
Results First Submitted: November 13, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Years]
Median (Full Range)
 41 
 (21 to 69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  25.8% 
Male      23  74.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      11  35.5% 
Not Hispanic or Latino      18  58.1% 
Unknown or Not Reported      2   6.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   3.2% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   3.2% 
White      26  83.9% 
More than one race      0   0.0% 
Unknown or Not Reported      3   9.7% 


  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)  

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 
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  

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 
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


  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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  More Information