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

History of Changes

Results First Received: November 13, 2013

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: No masking; Primary Purpose: Treatment
Condition:	Leukemia
Interventions:	Biological: epratuzumab Drug: clofarabine Drug: cytarabine Other: laboratory biomarker analysis

Participant Flow

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Recruitment Details

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Pre-Assignment Details

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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

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1. Primary:

Complete Remission [ Time Frame: After induction therapy was completed (1 or 2 months) ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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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