Phase 2 N=116 Treatment

Chemoimmunotherapy With Epratuzumab in Relapsed Acute Lymphoblastic Leukemia (ALL)

Recurrent Childhood Acute Lymphoblastic Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00098839 ↗

Enrolled (actual)

116

Serious AEs

31.6%

Results posted

Mar 2015

Primary outcome: Primary: Remission Re-induction (CR2) Rate — .646; .660 proportion of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: L-asparaginase (Drug); doxorubicin hydrochloride (Drug); therapeutic hydrocortisone (Drug); vincristine sulfate (Drug); epratuzumab (Biological); cytarabine (Drug); prednisone (Drug); pegaspargase (Drug); dexrazoxane hydrochloride (Drug); methotrexate (Drug); etoposide (Drug); cyclophosphamide (Drug); leucovorin calcium (Drug); filgrastim (Biological)
Age: Pediatric, Adult · 2+ yrs
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Remission Re-induction (CR2) Rate	.646; .660	—
PRIMARY Event-free Survival Rate	.604; .640	—
PRIMARY Rate of Minimal Residual Disease (MRD) < 0.01%	.195; .295	—
SECONDARY Pharmacokinetics	501	—

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 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.

Eligibility Criteria

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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00098839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.