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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

  Participant Flow

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

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

1.  Primary:   Complete Remission   [ Time Frame: After induction therapy was completed (1 or 2 months) ]
  Hide Outcome Measure 1

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 ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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