NcXHF

MANAGING OLDER PATIENTS WITH ALL
FIGURE 3. Treatment Schema for United Kingdom ALL 60 Trial Showing Four Treatment Arms and One
Registration Arm
1.1 Trial Schema
PH +ve
Informed Consent and Registraon
Treatment Choice*
PH -ve
Di c
bone
marrow*
*Treatment arm to be chosen by local
nsulta n with
nt and taking into account
performance status, co-morbidi
and personal preference.
Reason for choice will be
documented.
PHILADELPHIA POSITIVE
PHILADELPHIA NEGATIVE
(INTENSIVE)
PHILADELPHIA NEGATIVE
(INTENSIVE +)
PHILADELPHIA NEGATIVE
(NON-INTENSIVE)
REGISTRATION
ONLY
Phase 1
se 2
Bone marrow
for MRD*
Bone marrow
for MRD*
Bone marrow
for MRD*
Data
collecon
only
Consolid on 2
Bone marrow
for MRD*
Maintenance (2 years)
* Sample
sent to
central lab
-
s to be followed up annually from comple n of mai h
Four treatment arms ranging from very low to high intensity
are available to patients enrolled in the study (United
Kingdom CRN ID 12988; Fig. 3). The primary endpoints of
the study are CR rate after two cycles, event-free survival at 1
year, and treatment-related mortality. Further aims include
assessing quality of life (QOL), inpatient stays, and the prognostic
value of MRD at three time points. We will further
assess tolerability of treatment by assessing certain adverse
events.
The trial is accruing slowly, but to date we have preliminary
data about 39 patients from 21 centers. The median age of
patients is 67 and seven patients are Ph-pos. Twenty one have
been assigned to the intensive or very intensive arms. Only 18
patients are currently evaluable for response after phase II.
There has been no NRM, and 13 have achieved CR. Two patients
have died of ALL. These data will be updated just before
the 2015 ASCO Annual Meeting. HOVON and New
Zealand are planning to join the study.
During the next 3 years, we will collect data about postremission
therapy and its effect on QOL and need for hospitalization.
Having analyzed these data, in the next study we will
add in some novel agents aiming to improve effıcacy without
worsening toxicity.
UNITED KINGDOM ALL XIV TRIAL
To date, 394 of 720 planned patients have been recruited to
the United Kingdom ALL XIV multicenter study of adults
with ALL age 25 to 65. This randomized controlled trial is
evaluating up-front rituximab and nelarabine in B-cell and
T-cell disease respectively, as well as testing reduced intensity
allografting in high-risk patients older than age 40. The protocol
was amended after the fırst 92 patients because of excessive
NRM, mostly in older patients. The anthracycline
dose was halved (from 60 mg/m 2 to 30 mg/m 2 ) and doses of
PEG-asparaginase reduced from two to one or eliminated in
patients with Ph-pos disease.
One-hundred fıfty-two patients older than age 50 were entered
(139 patients with B-cell disease and 13 patients with
T-cell disease, median age 56.5). Philadelphia positivity was
seen in 38% of evaluable patients. CR was achieved in 26 of 39
evaluable pre-amendment patients, nine patients died with
evidence of leukemia, and four died of NRM (10%). NRM
will be analyzed in the patients older than 50 who were enrolled
in the study after the protocol amendment. To date, 17
of 137 evaluable patients have relapsed. Forty-four patients
older than 50 have proceeded to a RIC allograft (15 sibling
donors and 29 unrelated donors). The outcome of all patients
asco.org/edbook | 2015 ASCO EDUCATIONAL BOOK
e347