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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
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) 
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


  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 (87.10%) 
Blood and lymphatic system disorders   
Anemia †   
# participants affected / at risk   10/31 (32.26%) 
Febrile neutropenia †   
# participants affected / at risk   13/31 (41.94%) 
Cardiac disorders   
Sinus tachycardia †   
# participants affected / at risk   5/31 (16.13%) 
Ear and labyrinth disorders   
Ear pain †   
# participants affected / at risk   2/31 (6.45%) 
Eye disorders   
Blurred vision †   
# participants affected / at risk   2/31 (6.45%) 
Eye disorders - Other, specify †   
# participants affected / at risk   2/31 (6.45%) 
Gastrointestinal disorders   
Abdominal pain †   
# participants affected / at risk   5/31 (16.13%) 
Constipation †   
# participants affected / at risk   4/31 (12.90%) 
Diarrhea †   
# participants affected / at risk   13/31 (41.94%) 
Dysphagia †   
# participants affected / at risk   3/31 (9.68%) 
Mucositis oral †   
# participants affected / at risk   8/31 (25.81%) 
Nausea †   
# participants affected / at risk   19/31 (61.29%) 
Vomiting †   
# participants affected / at risk   12/31 (38.71%) 
General disorders   
Chills †   
# participants affected / at risk   5/31 (16.13%) 
Edema limbs †   
# participants affected / at risk   4/31 (12.90%) 
Fatigue †   
# participants affected / at risk   12/31 (38.71%) 
Fever †   
# participants affected / at risk   4/31 (12.90%) 
Injection site reaction †   
# participants affected / at risk   2/31 (6.45%) 
Localized edema †   
# participants affected / at risk   2/31 (6.45%) 
Infections and infestations   
Catheter related infection †   
# participants affected / at risk   2/31 (6.45%) 
Enterocolitis infectious †   
# participants affected / at risk   2/31 (6.45%) 
Gum infection †   
# participants affected / at risk   3/31 (9.68%) 
Lung infection †   
# participants affected / at risk   2/31 (6.45%) 
Papulopustular rash †   
# participants affected / at risk   2/31 (6.45%) 
Sepsis †   
# participants affected / at risk   4/31 (12.90%) 
Investigations   
Activated partial thromboplastin time prolonged †   
# participants affected / at risk   3/31 (9.68%) 
Alanine aminotransferase increased †   
# participants affected / at risk   10/31 (32.26%) 
Alkaline phosphatase increased †   
# participants affected / at risk   11/31 (35.48%) 
Aspartate aminotransferase increased †   
# participants affected / at risk   12/31 (38.71%) 
Blood bilirubin increased †   
# participants affected / at risk   3/31 (9.68%) 
Creatinine increased †   
# participants affected / at risk   2/31 (6.45%) 
INR increased †   
# participants affected / at risk   2/31 (6.45%) 
Lymphocyte count decreased †   
# participants affected / at risk   5/31 (16.13%) 
Neutrophil count decreased †   
# participants affected / at risk   10/31 (32.26%) 
Platelet count decreased †   
# participants affected / at risk   15/31 (48.39%) 
Weight loss †   
# participants affected / at risk   4/31 (12.90%) 
White blood cell decreased †   
# participants affected / at risk   9/31 (29.03%) 
Metabolism and nutrition disorders   
Anorexia †   
# participants affected / at risk   4/31 (12.90%) 
Hyperglycemia †   
# participants affected / at risk   14/31 (45.16%) 
Hyperkalemia †   
# participants affected / at risk   3/31 (9.68%) 
Hypermagnesemia †   
# participants affected / at risk   3/31 (9.68%) 
Hypernatremia †   
# participants affected / at risk   2/31 (6.45%) 
Hypoalbuminemia †   
# participants affected / at risk   12/31 (38.71%) 
Hypocalcemia †   
# participants affected / at risk   11/31 (35.48%) 
Hypoglycemia †   
# participants affected / at risk   4/31 (12.90%) 
Hypokalemia †   
# participants affected / at risk   8/31 (25.81%) 
Hypomagnesemia †   
# participants affected / at risk   6/31 (19.35%) 
Hyponatremia †   
# participants affected / at risk   5/31 (16.13%) 
Musculoskeletal and connective tissue disorders   
Back pain †   
# participants affected / at risk   2/31 (6.45%) 
Chest wall pain †   
# participants affected / at risk   2/31 (6.45%) 
Generalized muscle weakness †   
# participants affected / at risk   2/31 (6.45%) 
Pain in extremity †   
# participants affected / at risk   5/31 (16.13%) 
Nervous system disorders   
Dizziness †   
# participants affected / at risk   3/31 (9.68%) 
Headache †   
# participants affected / at risk   8/31 (25.81%) 
Peripheral sensory neuropathy †   
# participants affected / at risk   4/31 (12.90%) 
Psychiatric disorders   
Anxiety †   
# participants affected / at risk   2/31 (6.45%) 
Depression †   
# participants affected / at risk   2/31 (6.45%) 
Hallucinations †   
# participants affected / at risk   2/31 (6.45%) 
Insomnia †   
# participants affected / at risk   5/31 (16.13%) 
Respiratory, thoracic and mediastinal disorders   
Cough †   
# participants affected / at risk   6/31 (19.35%) 
Dyspnea †   
# participants affected / at risk   3/31 (9.68%) 
Epistaxis †   
# participants affected / at risk   3/31 (9.68%) 
Sore throat †   
# participants affected / at risk   6/31 (19.35%) 
Skin and subcutaneous tissue disorders   
Dry skin †   
# participants affected / at risk   5/31 (16.13%) 
Palmar-plantar erythrodysesthesia syndrome †   
# participants affected / at risk   2/31 (6.45%) 
Pruritus †   
# participants affected / at risk   7/31 (22.58%) 
Purpura †   
# participants affected / at risk   2/31 (6.45%) 
Rash acneiform †   
# participants affected / at risk   2/31 (6.45%) 
Rash maculo-papular †   
# participants affected / at risk   12/31 (38.71%) 
Skin and subcutaneous tissue disorders - Other †   
# participants affected / at risk   2/31 (6.45%) 
Skin ulceration †   
# participants affected / at risk   2/31 (6.45%) 
Vascular disorders   
Hematoma †   
# participants affected / at risk   3/31 (9.68%) 
Hypertension †   
# participants affected / at risk   6/31 (19.35%) 
Hypotension †   
# participants affected / at risk   2/31 (6.45%) 
Events were collected by systematic assessment



  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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