Table 1.

Pediatric Acute Lymphoblastic Leukemia Trials with Pegaspargase Associated Objectives

Cooperative Group/Study	Enrollment Period (N)	Asparaginase Objective(s)	Asparaginase Associated Findings
Upfront studies
DFCI 91–013	1991–1995 (377)	ASP intensification	Intensification improves outcomes
		PEG (IM) vs. L-asp (IM)	No significant difference in EFS with ASP preparation
CCG 196224	1997–1998 (187)	PEG (IM) vs. L-asp (IM)	PEG: increased clearance of blasts, decreased antibodies
AIEOP ALL 200050	2002 (20)	PEG (IV) as first line therapy	Adequate SAA and ASN depletion
DFCI 05–00133	2005–2010 (463)	PEG (IV) vs. L-asp (IM)	PEG: increased ASP course completion success and increased SAA No significant difference in DFS with ASP preparation
COG AALL07P434,38	2008–2010 (166)	PEG (IV) vs. CALASP (IV)	CALASP: prolonged SAA
DFCI 11–00139	2012–2015 (230)	PEG (IV) vs. CALASP (IV)	CALASP: prolonged SAA
Relapsed studies
CCG 194118	1995–1998 (93)	PEG (IM) in relapse	Decreased ASN led to increased second remission
CHMC 100151	1997–2001 (28)	PEG (IM) in relapse	Adequate SAA and ASN depletion

Abbreviations: DFCI, Dana-Farber Cancer Institute; CCG, Children’s Cancer Group; AIEOP, Associazione Italiana di Ematologia e Oncologia Pediatrica; COG, Children’s Oncology Group; CHMC, Children’s Hospital and Regional Medical Center; PEG, pegaspargase; L-asp, L-asparaginase; CALASP, calaspargase; ASP, asparaginase; IM, intramuscular; IV, intravenous; EFS, event-free survival; DFS, disease-free survival; SAA, serum asparaginase activity level; ASN, asparagine.