Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

Completed · Phase 1/Phase 2

Conditions studied: Recurrent Childhood Acute Lymphoblastic Leukemia

In brief

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 antibodies, such as epratuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing them or by stopping them from dividing. Giving monoclonal antibody therapy in combination chemotherapy may kill cancer cells more effectively.

Key facts

Study ID: NCT00098839
Run by: Children's Oncology Group
People needed: 134
Starts: 2005-02-01
Expected to finish: 2011-04-01
Last updated by the study team: 2017-12-12

Who can join

Age: 2 and older, up to 31. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
Loma Linda University Medical Center — Loma Linda, California, United States
Miller Children's Hospital — Long Beach, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
David Geffen School of Medicine at UCLA — Los Angeles, California, United States
Children's Hospital Central California — Madera, California, United States
Kaiser Permanente-Oakland — Oakland, California, United States
Childrens Hospital of Orange County — Orange, California, United States
Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Saint Joseph Children's Hospital of Tampa — Tampa, Florida, United States
Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
Indiana University Medical Center — Indianapolis, Indiana, United States
University of Kentucky — Lexington, Kentucky, United States
Tulane University Health Sciences Center — New Orleans, Louisiana, United States
Eastern Maine Medical Center — Bangor, Maine, United States
Johns Hopkins University — Baltimore, Maryland, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
C S Mott Children's Hospital — Ann Arbor, Michigan, United States
Wayne State University — Detroit, Michigan, United States
University of Minnesota Medical Center-Fairview — Minneapolis, Minnesota, United States
Mayo Clinic — Rochester, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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