Table 1.

Baseline demographics and disease characteristics

CharacteristicCohorts 1a and 1b (N = 125)Cohort 1a21 (N = 34)
Age (y), median (range) 69 (34-86) 68 (42-86) 
Sex, n (%)   
Male 80 (64) 23 (68) 
Female 45 (36) 11 (32) 
Race, n (%)   
White 108 (86) 32 (94) 
Black or African American 2 (2) 2 (6) 
Asian 15 (12) 0 (0) 
ECOG performance status, n (%)   
52 (42) 16 (47) 
67 (54) 18 (53) 
6 (5) 0 (0) 
Prior lines of therapy for MF, median (range) 1 (1-6) 1 (1-6) 
Baseline platelet count (×109/L), median (range) 201 (75-1469) 201 (98-706) 
Baseline spleen volume (cm3), median (range) 2128 (448-6219) 1695 (466-5047) 
Baseline white blood cell count (×109/L), median (range) 15 (2-205) 19 (5-205) 
Baseline hemoglobin (g/dL), median (range) 10 (5-15) 11 (7-15) 
Baseline hemoglobin ≥8 to <10 g/dL, n (%) 34 (27) 6 (18) 
Transfusion status, n (%)   
Dependent 6 (13) 4 (12) 
Independent 109 (87) 30 (88) 
Transfusion required ≤12 wk before study entry 32 (26) 6 (18) 
Baseline TSS, median (range) 17 (0-58) 14 (0-35) 
Time from diagnosis to study entry (mo), median (range) 43 (1-338) 28 (1-199) 
Duration of prior ruxolitinib exposure for MF treatment (wk), median (range) 95 (8-464) 70 (13-391) 
DIPSS risk at study entry, n (%)   
Intermediate-1 36 (29) 17 (50) 
Intermediate-2 71 (57) 12 (35) 
High 17 (14) 4 (12) 
JAK2 status at study entry, n (%)   
Detected 84 (72) 25 (78) 
CALR status at study entry, n (%)   
Detected 26 (22) 7 (22) 
MPL status at study entry, n (%)   
Detected 3 (3) 0 (0) 
HMR status at study entry , n (%)   
Detected 71 (61) 19 (59) 
CharacteristicCohorts 1a and 1b (N = 125)Cohort 1a21 (N = 34)
Age (y), median (range) 69 (34-86) 68 (42-86) 
Sex, n (%)   
Male 80 (64) 23 (68) 
Female 45 (36) 11 (32) 
Race, n (%)   
White 108 (86) 32 (94) 
Black or African American 2 (2) 2 (6) 
Asian 15 (12) 0 (0) 
ECOG performance status, n (%)   
52 (42) 16 (47) 
67 (54) 18 (53) 
6 (5) 0 (0) 
Prior lines of therapy for MF, median (range) 1 (1-6) 1 (1-6) 
Baseline platelet count (×109/L), median (range) 201 (75-1469) 201 (98-706) 
Baseline spleen volume (cm3), median (range) 2128 (448-6219) 1695 (466-5047) 
Baseline white blood cell count (×109/L), median (range) 15 (2-205) 19 (5-205) 
Baseline hemoglobin (g/dL), median (range) 10 (5-15) 11 (7-15) 
Baseline hemoglobin ≥8 to <10 g/dL, n (%) 34 (27) 6 (18) 
Transfusion status, n (%)   
Dependent 6 (13) 4 (12) 
Independent 109 (87) 30 (88) 
Transfusion required ≤12 wk before study entry 32 (26) 6 (18) 
Baseline TSS, median (range) 17 (0-58) 14 (0-35) 
Time from diagnosis to study entry (mo), median (range) 43 (1-338) 28 (1-199) 
Duration of prior ruxolitinib exposure for MF treatment (wk), median (range) 95 (8-464) 70 (13-391) 
DIPSS risk at study entry, n (%)   
Intermediate-1 36 (29) 17 (50) 
Intermediate-2 71 (57) 12 (35) 
High 17 (14) 4 (12) 
JAK2 status at study entry, n (%)   
Detected 84 (72) 25 (78) 
CALR status at study entry, n (%)   
Detected 26 (22) 7 (22) 
MPL status at study entry, n (%)   
Detected 3 (3) 0 (0) 
HMR status at study entry , n (%)   
Detected 71 (61) 19 (59) 

Data are n (%) unless stated otherwise.

CALR, calreticulin; ECOG, Eastern Cooperative Oncology Group.

One patient with SVR of <450 cm3 by central review was included because of a SVR of ≥450 cm3 by local review.

Defined as mutations in ASXL1, SRSF2, EZH2, U2AF1 (Q157), IDH1, or 1DH2.

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