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S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00945815
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : January 3, 2014
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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
Enrollment 35

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ara-C + Clofarabine + Epratuzumab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 35
Eligible 32
Eligible and Began Protocol Therapy 31
Completed 27
Not Completed 8
Reason Not Completed
Death             3
Not protocol specified             1
Ineligible             3
Did not begin protocol therapy             1
Arm/Group Title Ara-C + Clofarabine + Epratuzumab
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy were included in this analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
41
(21 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
8
  25.8%
Male
23
  74.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Hispanic or Latino
11
  35.5%
Not Hispanic or Latino
18
  58.1%
Unknown or Not Reported
2
   6.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 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%
1.Primary Outcome
Title Complete Remission
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy.
Arm/Group Title Ara-C + Clofarabine + Epratuzumab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52
(33 to 70)
2.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Treatment-Related Adverse Events
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries.
Arm/Group Title Ara-C + Clofarabine + Epratuzumab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: 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
Time Frame Up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ara-C + Clofarabine + Epratuzumab
Hide Arm/Group Description 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.
All-Cause Mortality
Ara-C + Clofarabine + Epratuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ara-C + Clofarabine + Epratuzumab
Affected / at Risk (%)
Total   15/31 (48.39%) 
Blood and lymphatic system disorders   
Anemia   1/31 (3.23%) 
Febrile neutropenia   6/31 (19.35%) 
Cardiac disorders   
Cardiac arrest   2/31 (6.45%) 
Gastrointestinal disorders   
Abdominal pain   1/31 (3.23%) 
Diarrhea   2/31 (6.45%) 
Oral pain   1/31 (3.23%) 
Typhlitis   1/31 (3.23%) 
General disorders   
Death NOS   1/31 (3.23%) 
Hepatobiliary disorders   
Hepatic failure   1/31 (3.23%) 
Infections and infestations   
Catheter related infection   3/31 (9.68%) 
Enterocolitis infectious   1/31 (3.23%) 
Lung infection   3/31 (9.68%) 
Sepsis   4/31 (12.90%) 
Tooth infection   1/31 (3.23%) 
Investigations   
Alanine aminotransferase increased   2/31 (6.45%) 
Aspartate aminotransferase increased   2/31 (6.45%) 
Investigations - Other, specify   1/31 (3.23%) 
Neutrophil count decreased   1/31 (3.23%) 
Platelet count decreased   2/31 (6.45%) 
Metabolism and nutrition disorders   
Hypocalcemia   1/31 (3.23%) 
Hypokalemia   1/31 (3.23%) 
Hyponatremia   1/31 (3.23%) 
Hypophosphatemia   1/31 (3.23%) 
Nervous system disorders   
Encephalopathy   2/31 (6.45%) 
Nervous system disorders - Other, specify   1/31 (3.23%) 
Transient ischemic attacks   1/31 (3.23%) 
Renal and urinary disorders   
Acute kidney injury   1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia   1/31 (3.23%) 
Respiratory failure   2/31 (6.45%) 
Vascular disorders   
Hypotension   1/31 (3.23%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ara-C + Clofarabine + Epratuzumab
Affected / at Risk (%)
Total   27/31 (87.10%) 
Blood and lymphatic system disorders   
Anemia   10/31 (32.26%) 
Febrile neutropenia   13/31 (41.94%) 
Cardiac disorders   
Sinus tachycardia   5/31 (16.13%) 
Ear and labyrinth disorders   
Ear pain   2/31 (6.45%) 
Eye disorders   
Blurred vision   2/31 (6.45%) 
Eye disorders - Other, specify   2/31 (6.45%) 
Gastrointestinal disorders   
Abdominal pain   5/31 (16.13%) 
Constipation   4/31 (12.90%) 
Diarrhea   13/31 (41.94%) 
Dysphagia   3/31 (9.68%) 
Mucositis oral   8/31 (25.81%) 
Nausea   19/31 (61.29%) 
Vomiting   12/31 (38.71%) 
General disorders   
Chills   5/31 (16.13%) 
Edema limbs   4/31 (12.90%) 
Fatigue   12/31 (38.71%) 
Fever   4/31 (12.90%) 
Injection site reaction   2/31 (6.45%) 
Localized edema   2/31 (6.45%) 
Infections and infestations   
Catheter related infection   2/31 (6.45%) 
Enterocolitis infectious   2/31 (6.45%) 
Gum infection   3/31 (9.68%) 
Lung infection   2/31 (6.45%) 
Papulopustular rash   2/31 (6.45%) 
Sepsis   4/31 (12.90%) 
Investigations   
Activated partial thromboplastin time prolonged   3/31 (9.68%) 
Alanine aminotransferase increased   10/31 (32.26%) 
Alkaline phosphatase increased   11/31 (35.48%) 
Aspartate aminotransferase increased   12/31 (38.71%) 
Blood bilirubin increased   3/31 (9.68%) 
Creatinine increased   2/31 (6.45%) 
INR increased   2/31 (6.45%) 
Lymphocyte count decreased   5/31 (16.13%) 
Neutrophil count decreased   10/31 (32.26%) 
Platelet count decreased   15/31 (48.39%) 
Weight loss   4/31 (12.90%) 
White blood cell decreased   9/31 (29.03%) 
Metabolism and nutrition disorders   
Anorexia   4/31 (12.90%) 
Hyperglycemia   14/31 (45.16%) 
Hyperkalemia   3/31 (9.68%) 
Hypermagnesemia   3/31 (9.68%) 
Hypernatremia   2/31 (6.45%) 
Hypoalbuminemia   12/31 (38.71%) 
Hypocalcemia   11/31 (35.48%) 
Hypoglycemia   4/31 (12.90%) 
Hypokalemia   8/31 (25.81%) 
Hypomagnesemia   6/31 (19.35%) 
Hyponatremia   5/31 (16.13%) 
Musculoskeletal and connective tissue disorders   
Back pain   2/31 (6.45%) 
Chest wall pain   2/31 (6.45%) 
Generalized muscle weakness   2/31 (6.45%) 
Pain in extremity   5/31 (16.13%) 
Nervous system disorders   
Dizziness   3/31 (9.68%) 
Headache   8/31 (25.81%) 
Peripheral sensory neuropathy   4/31 (12.90%) 
Psychiatric disorders   
Anxiety   2/31 (6.45%) 
Depression   2/31 (6.45%) 
Hallucinations   2/31 (6.45%) 
Insomnia   5/31 (16.13%) 
Respiratory, thoracic and mediastinal disorders   
Cough   6/31 (19.35%) 
Dyspnea   3/31 (9.68%) 
Epistaxis   3/31 (9.68%) 
Sore throat   6/31 (19.35%) 
Skin and subcutaneous tissue disorders   
Dry skin   5/31 (16.13%) 
Palmar-plantar erythrodysesthesia syndrome   2/31 (6.45%) 
Pruritus   7/31 (22.58%) 
Purpura   2/31 (6.45%) 
Rash acneiform   2/31 (6.45%) 
Rash maculo-papular   12/31 (38.71%) 
Skin and subcutaneous tissue disorders - Other   2/31 (6.45%) 
Skin ulceration   2/31 (6.45%) 
Vascular disorders   
Hematoma   3/31 (9.68%) 
Hypertension   6/31 (19.35%) 
Hypotension   2/31 (6.45%) 
Indicates events were collected by systematic assessment
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 )
First Submitted: July 23, 2009
First Posted: July 24, 2009
Results First Submitted: November 13, 2013
Results First Posted: January 3, 2014
Last Update Posted: November 6, 2017