This is a compilation of results of important clinical trials those have used Rituximab in patients of pre-B ALL (BCR ABL negative or positive). This includes studies from MDACC USA, French group GRAALL, UKALL14 and also from TMH Mumbai, India.
4. Rituximab in B-ALL
Centre/
Trial
Year of
publicati
on
No. of
patients
Inclusion Backbon
e
CD20
expressi
on
Rituxima
b total
doses
Rituxima
b
schedule
CR/MRD
neg rates
OS EFS
MDACC 2010 282 Ph-ve
>10yr
Hyper-
CVAD
>20% 12 In
protocol
No diff 3yr OS
75% vs
47%
historical
P=0.003
GRAALL 2005 209 Ph-ve
18-59yr
GRAALL >20% 16-18 In
protocol
CR/MRD-
No diff
HR=0.7
p=0.1
HR=0.66
p=0.04
UKALL14 2022 586 Ph+/-
19-65yr
UKALL14 Any
CD20
4 day 3,
10, 17,
24
CR/
MRD- No
diff
- 3yr EFS
43.7 Vs
51.4
TMH,
Mumbai
2021 35 Ph-ve
>14yr
BFM-90
(Ritux+
Bort)
>20% 5 day 1, 8,
15, 22,
28
CR- 85.3%
Vs 70%.
MRD neg-
70.9% Vs
51.7%
historical
21m
78.8%
21m
78.7%
5. Salient points
Steroids upregulate CD 20 expression
So level of expression of CD 20 may not make a difference
So logical to use R after few days of steroids
Benefit or R irrespective of Ph status
4 doses are inadequate for OS benefit
R can decrease anti-L-asp Ab formation & thus resistance