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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 20, 2017
Last verified: April 2017
Results First Received: 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
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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 
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
  Show All Outcome Measures

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 ]
  Hide Outcome Measure 2

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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: SWOG Leukemia Statistician
Organization: SWOG Statistical Center
phone: 206-667-4408



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00945815     History of Changes
Other Study ID Numbers: S0910
S0910 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
Study First Received: July 23, 2009
Results First Received: November 13, 2013
Last Updated: April 20, 2017