Status:
COMPLETED
Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Childhood Acute Lymphoblastic Leukemia
Eligibility:
All Genders
2-31 years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase II trial is studying how well giving epratuzumab together with an established chemotherapy platform works in treating young patients with relapsed acute lymphoblastic leukemia. Monoclonal a...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the feasibility of epratuzumab administered alone and in combination with re-induction combination chemotherapy in pediatric patients with relapsed CD22-positive acut...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of B lymphoblastic leukemia (B-ALL)
- At least 25% expression of CD22 by immunophenotyping
- In marrow relapse (M3 bone marrow) with or without associated extramedullary disease as defined by 1 of the following:
- In first or later marrow relapse occurring any time after initial diagnosis (part A \[closed to accrual as of 10/30/06\] or B)
- In first, early marrow relapse with or without associated extramedullary disease occurring \< 36 months from the time of initial diagnosis (part B only)
- No B-cell L3 morphology OR evidence of a regulator gene that codes for a transcription factor (MYC) translocation by molecular or cytogenetic analysis
- No Down syndrome
- Patients with CNS or other extramedullary site involvement are allowed
- Performance status - Karnofsky 50-100% (for patients \> 10 years of age)
- Performance status - Lansky 50-100% (for patients ≤ 10 years of age)
- White Blood Count (WBC) ≤ 50,000/mm\^3 (part A only \[closed to accrual as of 10/30/06\])
- Bilirubin ≤ 1.5 times upper limit of normal unless disease-related (ULN)
- Alanine aminotransferase (ALT) ≤ 5 times ULN
- Albumin ≥ 2 g/dL
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
- Creatinine as defined by age as follows:
- ≤ 0.5 mg/dL (for patients \< 1 year old)
- ≤ 0.8 mg/dL (for patients 1 to 5 years old)
- ≤ 1.0 mg/dL (for patients 6 to 10 years old)
- ≤ 1.2 mg/dL (for patients 11 to 15 years old)
- ≤ 1.5 mg/dL (for patients \> 15 years old)
- Shortening fraction ≥ 27% by echocardiogram
- Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA)
- No dyspnea at rest
- No exercise intolerance
- Pulse oximetry \> 94%
- No active or uncontrolled infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Recovered from prior immunotherapy
- At least 4 months since prior stem cell transplantation or rescue AND no evidence of active graft-vs-host disease
- At least 7 days since prior hematopoietic growth factors
- At least 7 days since prior biologic therapy\*
- No other concurrent immunotherapy
- No other concurrent biologic therapy
- Recovered from prior chemotherapy
- No waiting period for children who relapse while receiving standard ALL maintenance therapy
- No prior cumulative anthracycline exposure \> 400 mg/m\^2\*
- No concurrent chemotherapy
- Recovered from prior radiotherapy
- No concurrent radiotherapy
- At least 2 days since prior hydroxyurea
- No other concurrent investigational drugs
- No other concurrent anticancer agents
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00098839
Start Date
February 1 2005
End Date
April 1 2011
Last Update
December 12 2017
Active Locations (46)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
3
Miller Children's Hospital
Long Beach, California, United States, 90806
4
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027