Table 1. Patients characteristics in... | American Society of Hematology

Table 1.

Patients characteristics in randomized patients (by intention to treat)

	2× P-III		P-II		Total
	N	%	N	%	N	%
Total patients	1023		1018		2041
Sex
Male	601	58.7	561	55.1	1162	56.9
Female	422	41.3	457	44.9	879	43.1
Age, y
1-9	795	77.7	795	78.1	1590	77.9
10-17	228	22.3	223	21.9	451	22.1
White blood cell count
<20 000/μL	688	67.3	706	69.4	1394	68.3
20-100 000/μL	263	25.7	253	24.8	516	25.3
≥100 000/μL	72	7.0	59	5.8	131	6.4
CNS involvement
No (CNS1-CNS2)	983	96.1	972	95.5	1955	95.8
Yes (CNS3)	21	2.1	28	2.8	49	2.4
Not known	19	1.8	18	1.7	37	1.8
Immunophenotype
Bcp-ALL	896	87.6	887	87.1	1783	87.4
T-ALL	107	10.5	115	11.3	222	10.9
Not known	20	1.9	16	1.6	36	1.7
National Cancer Institute criteria
Standard	686	67.1	676	66.4	1362	66.7
High	337	32.9	342	33.6	679	33.3
Random in induction
Dexamethasone	397	38.8	404	39.7	801	39.2
Prednisone	430	42.0	419	41.1	849	41.6
Not performed	196	19.2	195	19.2	391	19.2
*ETV6-RUNX1*
Positive	193	18.9	176	17.3	369	18.1
Negative	728	71.1	744	73.1	1472	72.1
Not known	102	10.0	98	9.6	200	9.8
MRD levels at TP1*
<5 × 10⁻⁴	469	67.2	464	68.8	933	68.0
≥5 × 10⁻⁴	229	32.8	210	31.2	439	32.0
MRD levels at TP2*
Negative	461	66.1	459	68.1	920	67.1
<5 × 10⁻⁴	237	33.9	215	31.9	452	32.9

	2× P-III		P-II		Total
	N	%	N	%	N	%
Total patients	1023		1018		2041
Sex
Male	601	58.7	561	55.1	1162	56.9
Female	422	41.3	457	44.9	879	43.1
Age, y
1-9	795	77.7	795	78.1	1590	77.9
10-17	228	22.3	223	21.9	451	22.1
White blood cell count
<20 000/μL	688	67.3	706	69.4	1394	68.3
20-100 000/μL	263	25.7	253	24.8	516	25.3
≥100 000/μL	72	7.0	59	5.8	131	6.4
CNS involvement
No (CNS1-CNS2)	983	96.1	972	95.5	1955	95.8
Yes (CNS3)	21	2.1	28	2.8	49	2.4
Not known	19	1.8	18	1.7	37	1.8
Immunophenotype
Bcp-ALL	896	87.6	887	87.1	1783	87.4
T-ALL	107	10.5	115	11.3	222	10.9
Not known	20	1.9	16	1.6	36	1.7
National Cancer Institute criteria
Standard	686	67.1	676	66.4	1362	66.7
High	337	32.9	342	33.6	679	33.3
Random in induction
Dexamethasone	397	38.8	404	39.7	801	39.2
Prednisone	430	42.0	419	41.1	849	41.6
Not performed	196	19.2	195	19.2	391	19.2
*ETV6-RUNX1*
Positive	193	18.9	176	17.3	369	18.1
Negative	728	71.1	744	73.1	1472	72.1
Not known	102	10.0	98	9.6	200	9.8
MRD levels at TP1*
<5 × 10⁻⁴	469	67.2	464	68.8	933	68.0
≥5 × 10⁻⁴	229	32.8	210	31.2	439	32.0
MRD levels at TP2*
Negative	461	66.1	459	68.1	920	67.1
<5 × 10⁻⁴	237	33.9	215	31.9	452	32.9

Bcp, B-cell precursor; CNS, central nervous system; T-ALL, T-cell acute lymphoblastic leukemia.

MRD was not known in 666 patients (32.6%) overall (322 in protocol [P]-III ×2 and 344 in protocol II).