J Hematol

Journal of Hematology, ISSN 1927-1212 print, 1927-1220 online, Open Access

Article copyright, the authors; Journal compilation copyright, J Hematol and Elmer Press Inc

Journal website https://www.thejh.org

Short Communication

Volume 9, Number 3, September 2020, pages 79-83

Ofatumumab and Complement Replacement in Relapsed/Refractory Chronic Lymphocytic Leukemia

**Table 1.** Patient Baseline Characteristics
Patient number	Age (years)	Gender	Comorbidities	Mutations on FISH	Prior regimens (number)	Most recent regimen prior to enrollment	Response to most recent regimen
BR: bendamustine/rituximab; FCR: fludarabine/cyclophosphamide/rituximab; CR: complete response; PR: partial response; CAD: coronary artery disease; CHF: congestive heart failure; CVD: cerebrovascular disease; DM2: diabetes mellitus type 2; HTN: hypertension; SVT: supraventricular tachycardia; SD: stable disease; FISH: fluorescence in situ hybridization.
1	75	Male	DM2, CVD, HTN	Del (17p)	4	Rituximab	CR
2	54	Male	SVT	Del (13q)	1	Rituximab	PR
3	59	Female	None	Del (17p)/trisomy 12	1	FCR	CR
4	67	Male	DM2	Del (17p)	3	Rituximab	PR
5	71	Male	HTN, CAD, hypothyroidism	Del (13q)	3	Rituximab	PR
6	76	Male	HTN, atrial fibrillation	Del (11q)/del (13q)	1	Fludarabine/rituximab	CR
7	50	Male	None	Del (13q)	4	BR	SD
8	62	Male	None	Del (11q)/del (13q)	5	Idelalisib	PR
9	71	Male	CVD, CAD, CHF, prostate cancer	Del (11q)/del (13q)	1	FCR light	PR
10	64	Male	HTN, hypothyroidism, hyperprolactinemia	Del (13q)	1	Rituximab	CR
11	64	Female	None	Trisomy 12	1	Rituximab	CR
12	61	Male	None	Del (13q)/del (17p)	1	BR	PR

Table 1. Patient Baseline Characteristics

Patient number

Age (years)

Gender

Comorbidities

Mutations on FISH

Prior regimens (number)

Most recent regimen prior to enrollment

Response to most recent regimen

BR: bendamustine/rituximab; FCR: fludarabine/cyclophosphamide/rituximab; CR: complete response; PR: partial response; CAD: coronary artery disease; CHF: congestive heart failure; CVD: cerebrovascular disease; DM2: diabetes mellitus type 2; HTN: hypertension; SVT: supraventricular tachycardia; SD: stable disease; FISH: fluorescence in situ hybridization.

Male

DM2, CVD, HTN

Del (17p)

Rituximab

Male

SVT

Del (13q)

Rituximab

Female

None

Del (17p)/trisomy 12

FCR

Male

DM2

Del (17p)

Rituximab

Male

HTN, CAD, hypothyroidism

Del (13q)

Rituximab

Male

HTN, atrial fibrillation

Del (11q)/del (13q)

Fludarabine/rituximab

Male

None

Del (13q)

Male

None

Del (11q)/del (13q)

Idelalisib

Male

CVD, CAD, CHF, prostate cancer

Del (11q)/del (13q)

FCR light

Male

HTN, hypothyroidism, hyperprolactinemia

Del (13q)

Rituximab

Female

None

Trisomy 12

Rituximab

Male

None

Del (13q)/del (17p)

**Table 2.** Complement Levels and Activity
Patient number	Baseline C3 (mg/dL)	Baseline C4 (mg/dL)	Baseline CH50 (U/mL)	Week 2 C3 (%Δ)^a	Week 2 C4 (%Δ)	Week 2 CH50 (%Δ)	Best response
^aPercent change from baseline; ^bLow complement values (normal range: C3: 92 - 210 mg/dL, C4: 18 - 56 mg/dL, CH50: 60 - 144 U/mL). CR: complete response; PR: partial response.
1	154	42	111	125 (-19)	22 (-48)	105 (-5)	PR
2	113	29	127	87 (-23)	4.9^b (-83)	0^b (-127)	PR
3	148	31	136	99 (-33)	4.9^b (-84)	35^b (-74)	CR
4	153	45	193	128 (-16)	20 (-56)	110 (-43)	CR
5	133	30	77	114 (-14)	7^b (-77)	58^b (-25)	PR
6	89^b	4.9^b	17^b	79 (-11)	4.9^b (0)	1^b (-94)	PR
7	88^b	14^b	79	85 (-3)	4.9^b (-64)	32^b (-59)	PD
8	187	45	145	134 (-22)	9^b (-80)	52^b (-64)	PD
9	125	26	95	118 (-6)	17^b (-35)	111 (+17)	PR
10	141	31	145	143 (+1)	25 (-19)	114 (-20)	PR
11	128	24	146	107 (-16)	5^b (-79)	15^b (-90)	PR
12	100	20	117	84 (-16)	4.9^b (-75)	40^b (-66)	PR

Table 2. Complement Levels and Activity

Patient number

Baseline C3 (mg/dL)

Baseline C4 (mg/dL)

Baseline CH50 (U/mL)

Week 2 C3 (%Δ)^a

Week 2 C4 (%Δ)

Week 2 CH50 (%Δ)

Best response

^aPercent change from baseline; ^bLow complement values (normal range: C3: 92 - 210 mg/dL, C4: 18 - 56 mg/dL, CH50: 60 - 144 U/mL). CR: complete response; PR: partial response.

154

111

125 (-19)

22 (-48)

105 (-5)

113

127

87 (-23)

4.9^b (-83)

0^b (-127)

148

136

99 (-33)

4.9^b (-84)

35^b (-74)

153

193

128 (-16)

20 (-56)

110 (-43)

133

114 (-14)

7^b (-77)

58^b (-25)

89^b

4.9^b

17^b

79 (-11)

4.9^b (0)

1^b (-94)

88^b

14^b

85 (-3)

4.9^b (-64)

32^b (-59)

187

145

134 (-22)

9^b (-80)

52^b (-64)

125

118 (-6)

17^b (-35)

111 (+17)

141

145

143 (+1)

25 (-19)

114 (-20)

128

146

107 (-16)

5^b (-79)

15^b (-90)

100

117

84 (-16)

4.9^b (-75)

40^b (-66)