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A.S. Mims et al.
ential statistical tests of hypotheses were planned. Data collected are descriptive and provide limited estimates of variability given the small patient sample size at each dose level.
Results
Patient characteristics and treatment groups
Seventeen adults with relapsed/refractory AML were treated on this phase I study. The median age of patients
Table 2. Patient Characteristics.
was 46 years (range, 21-59 years). Median white blood cell count and bone marrow blast percentage was 3.5 x 103/mL (range, 0.4-75.8) and 66% (range, 4-87%), respec- tively. The median number of prior induction therapies was 2 (range, 1-4). All patients had previous anthracycline exposure, and 15 patients had previous high-dose cytara- bine exposure. Twelve patients had relapsed disease, with 8 patients having prior CR1 duration of less than 1 year and 4 patients experiencing CR1 ranging from 16-38 months. Five patients had primary refractory disease;
Patient Age/ Sex
# of prior inductions
1
3 2 4
1
1 2
2 2
4
3
2 4
3
1
2
2
Pretreatment karyotype
KMT2A
PTD
Initial Initial Dose WBC blast Level
count
Length of 1st CR (mos)
6
17 10 n/a
18
16 n/a
n/a n/a
38
2
10 11
3
10
n/a
1
2 3 4
5
6 7
8 9
10
11
12 13
14
. 15 16
17
58/F
45/F 46/M 25/M
58/F
54/M 50/M
42/F 26/F
59/M
24/F
42/M 27/F
21/F
58/M
58/F
57/M
46,XX,t(12;22)(q13;q13)[15]/42-45,XX,-2,add(3) n/a
(p25),del(3)(p24),-11,-17,add
(17)(p11.2),der(19)t(17;19)(q21;p12),+mar1,+mar2[4]/46,XX[1]
46, XX [19]/nonclonal[1] n/e 3.5 79 1 47,XY,+11 [2]/47, idem, t(16;21)(p11.2;q22)[18] n/e 3.3 77 1
40.9 81 1
45,XY,der n/a
dic(13;18)(q21;p11.3)ins(13;?)(q21;?)[13]/45,idem,t(10;12)
(p13;q13)[cp2]/46,XY[5]/nonclonal[2]
47,XX,t(16;16)(p13.1;q22),+22[14]/nonclonal PTD+
w/clonal abnormalities [1]/46,XX[7]
46,XY[19]/nonclonal[1] neg
43,XY,del(4)(q31),-5,-12,del(13)(q12q14),- n/e 15,add(17)(q25),add(18)(q12),add(19)(p13.3),add(20)
(q13.3),add(21)(q22)[1]/ 42-44,sl,-Y,add(6)(p21),
+i(8)(q10)[cp3]/ 43,sdl1,-add(6),+del(6)(p23)
[cp6]/ 42-44,sl,+8,add(22)(q22)[cp4]/ 43,sl,-Y,+5,-
45,XX,-7[20] neg
46,XX,t(1;16)(p32;p13.1),der(3)t(3;17)(q29;q11.2), PTD+
der(5)t(5;9)(q11.2;q21),add(8)(q22),- 9,add(12)(q13),der(12)t(12;12)(p13;q13)ins(12;17)
(p13;q11.2q21),+16,der(16)t(1;16),-17,-17,-18,add(22)(q13),+mar1, +mar2,+mar3[12]/45,sl,-der(16)t(1;16)(p32;p13.1),+der(16)t(1;16) (p32;p13.1)add(1) (p36.3)[2]/46,sl,del(6)(q13q25)
[1]/nonclonal w/clonal abnormalities[1]/46,XX[4] 45,XY,t(3;12)(q26;p13),t(4;5)(q21;q31),del(5) neg (q15q35),-7,t(10;21)(q22;q22)[cp1] 46,XX,del(11)(p13p15.1)[16]/nonclonal neg w/clonal abnormalities[4] 46,XY,der(12)t(12;21)(p12;q11.2)[19]/nonclonal[1] neg 46,XX,dup(2)(q21q31),t(8;21)(q22;q22)[18]/nonclonal PTD+ w/clonal abnormalities[1]/46,XX[1] 47,XX,der(10)t(10;11)(p11.2;q13)inv(11)(q13q23), PTD+ der(11)t(10;11)(p11.2;q13),+mar1[cp7]/47,idem,add(X) (q26),add(8)(q24.1),add(13)(p11.2),-15,add(18)
(p11 2),+21,-mar1,+mar2[cp15]/nonclonal w/clonal abnormalities[2] 46,XY,t(3;15)(p13;q13)[16]/47,idem,+13[2]/46,XY[1]/nonclonal[1] n/a 46,XX,del(12)(p11.2p13)[1]/45,sl,del(19)(q13.3), neg -20,add(21)(q22)[3]/45,sdl1,-7[2]/45,sdl2,-20[2]/46,XX[12]
45,X,-Y[20] neg
3.2 40 1
2.2 22 1
1.3 36 1 5.9 8 2
22.1 66 2 2.0 51 2
3.2 4 3
75.8 82 3
4.0 87 3 0.4 66 4
17.8 82 4
30.5 83 4
2.1 69 4
36.6 66 4
6
984
CR: cytogenetic remission; F: female; M: male; mos: month; n/a: not applicable; n/e: not evaluable; WBC: white blood.
haematologica | 2018; 103(6)