S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00945815
First received: July 23, 2009
Last updated: December 1, 2014
Last verified: December 2014
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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
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| 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. |
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| 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 | |
|---|---|
|
Number of Participants
[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
Show All 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) |
| Safety Issue | No |
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 | |
|---|---|
|
Number of 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 ] |
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 |
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| No text entered. |