Written in Blood
In the phase I trial, researchers evaluated two
concentrations of topical resiquimod gel (0.06%
and 0.03%) applied to a limited number of skin
lesions in a small group of patients with stage IA
and IIA CTCL.
All patients had a pretreatment, four-week
washout period to discontinue prior CTCL
therapies, and were then instructed to apply up
to 500 mg of resiquimod gel to four target lesions
in the 0.06 percent group or up to five target lesions in the 0.03 percent group. Dosing started at
Table 5 Post-Baseline Laboratory Abnormalities by
CTCAE Grade in ≥ 5% of Patients and at Least 2%
Greater in the GAZYVA Treated Arm (Stage 1)
GAZYVA
+ Chlorambucil
n = 241
Investigations
Chlorambucil
n = 116
All
Grades
All
Grades
Grades % 3–4 % Grades % 3–4 %
Hematology
Neutropenia
78
48
53
27
Lymphopenia
80
40
9
3
Leukopenia
84
37
12
<1
Chemistry
Hypocalcemia
38
3
33
2
Hyperkalemia
33
5
18
3
Hyponatremia
30
8
12
3
AST
(SGOT increased)
29
1
16
0
Creatinine
increased
30
<1
20
2
ALT
(SGPT increased)
27
2
16
0
Hypoalbuminemia
23
<1
15
<1
Alkaline phosphatase 18
increased
0
11
0
Hypokalemia
1
5
<1
15
Table 6 Post-Baseline Laboratory Abnormalities by
CTCAE Grade in ≥ 5% of Patients and at Least 2%
Greater in the GAZYVA Treated Arm (Stage 2)
Investigations
GAZYVA
+ Chlorambucil
n = 336
Rituximab
+ Chlorambucil
n = 321
All
Grades
All
Grades
Grades % 3–4 % Grades % 3–4 %
Hematology
Neutropenia
76
46
69
41
Lymphopenia
80
39
50
16
Leukopenia
16
84
35
62
Thrombocytopenia 48
13
40
8
Anemia
39
10
37
10
Chemistry
Hypocalcemia
37
3
32
<1
Hyperkalemia
14
1
10
<1
Hyponatremia
26
7
18
2
AST
27
(SGOT increased)
2
21
<1
ALT
28
(SGPT increased)
2
21
1
Hypoalbuminemia 23
<1
16
<1
Infusion Reactions: The incidence of infusion reactions
was 65% with the first infusion of GAZYVA. The incidence
of Grade 3 or 4 infusion reactions was 20% with 7% of
patients discontinuing therapy. The incidence of reactions
with subsequent infusions was 3% with the second 1000
mg and < 1% thereafter. No Grade 3 or 4 infusion reactions
were reported beyond the first 1000 mg infused.
Of the first 53 patients receiving GAZYVA on the trial,
47 (89%) experienced an infusion reaction. After this
experience, study protocol modifications were made to
require pre-medication with a corticosteroid, antihistamine,
and acetaminophen. The first dose was also divided into
two infusions