Table 2. Recent completed phase 3 trials... | American Society of Hematology

Table 2.

Recent completed phase 3 trials for first ALL relapse

Trial	Years of accrual	Patient age (y)	No. of patients	Outcomes
UKALL R3¹⁵	2003-2009	1-18	239 (216 randomized)	3-y PFS 65%; 3-y OS 69% (mitoxantrone arm)
NCT00967057	2003-2009	1-18	239 (216 randomized)	3-y PFS 65%; 3-y OS 69% (mitoxantrone arm)
ALL-REZ-BFM 2002¹⁶	2003-2012	1-18	538 (420 randomized)	5-y EFS 60%; 5-y OS 69% (Prot II-IDA arm)
NCT00114348	2003-2012	1-18	538 (420 randomized)	5-y EFS 60%; 5-y OS 69% (Prot II-IDA arm)
COG AALL0433¹⁰	2007-2013	1-30	275* (271 eligible)	3-y EFS 64%; 3-y OS 72%
NCT00381680	2007-2013	1-30	275* (271 eligible)	3-y EFS 64%; 3-y OS 72%
COG AALL1331¹⁷	2014-2019	1-30	220† (208 randomized)	2-y disease-free survival 59%; 2-y OS 79% (blinatumomab arm)
NCT02101853	2014-2019	1-30	220† (208 randomized)

Trial	Years of accrual	Patient age (y)	No. of patients	Outcomes
UKALL R3¹⁵	2003-2009	1-18	239 (216 randomized)	3-y PFS 65%; 3-y OS 69% (mitoxantrone arm)
NCT00967057	2003-2009	1-18	239 (216 randomized)	3-y PFS 65%; 3-y OS 69% (mitoxantrone arm)
ALL-REZ-BFM 2002¹⁶	2003-2012	1-18	538 (420 randomized)	5-y EFS 60%; 5-y OS 69% (Prot II-IDA arm)
NCT00114348	2003-2012	1-18	538 (420 randomized)	5-y EFS 60%; 5-y OS 69% (Prot II-IDA arm)
COG AALL0433¹⁰	2007-2013	1-30	275* (271 eligible)	3-y EFS 64%; 3-y OS 72%
NCT00381680	2007-2013	1-30	275* (271 eligible)	3-y EFS 64%; 3-y OS 72%
COG AALL1331¹⁷	2014-2019	1-30	220† (208 randomized)	2-y disease-free survival 59%; 2-y OS 79% (blinatumomab arm)
NCT02101853	2014-2019	1-30	220† (208 randomized)

Late isolated or combined marrow and very early isolated CNS.

Intermediate and high risk only.