Haplo-identical transplant: long-term follow-up of a three-steps phase I/II study of the impact of post-transplant growth factors and GSF-primed DLI in advanced acute leukaemia patients

Ref ID: 18632

Author:

P. Lewalle (1), R. Rouas (1), A. Delforge (1), P. Crombez (1),
N. Meuleman (1), J. Maertens (2), D. Bron (1), P. Martiat (1)

Author address:

(1)Institut Bordet (ULB) (Brussels, BE); (2)KULeuven (Leuven, BE)

Full conference title:

Annual Meeting of the EBMT, 37th

Abstract:

Introduction: we initiated this study in 2000, at a time where
most referred patients (without a matched donor) were in very
advanced stage (most of them refractory or progressive), in
order to evaluate the impact of G-CSF and GM-CSF post-transplant, and the role of G-CSF primed DLI. It is worth noting that,
with time, the proportion of patients in CR (mainly CR2 and
CR3) increased.
Patients and methods: a total of 45 patients entered this study
of whom 17 were in refractory or progressive relapse, 9 in PR
post relapse, 16 in CR 2 or 3 and 2 in CR1. The three steps
consisted of (1) G-CSF + DLI (10
4
per kg) monthly from day 30
if no GVHD, (2) GM-CSF from day 5 + one single DLI at day
30, GM-CSF (day 5 to 9) without DLI for patients who could not
benefi t from NK alloreactivity (ALL and some AML). There were
9 patients in step I, 12 in step II and 22 in step III. The median
reinfused cell dose was 4.4×10
6
/kg and 4.8×10
4
/kg for CD34+
and CD3+ cells respectively.
Results: for step I (2 CR), 1/9 grade III GVHD, TRM = 0 at
day 100 and 2 at 3 years, a low incidence (25%) of CMV and
aspergillosis, but 6/9 eventually relapsed. For step II, the TRM
was 8/12 due to a high incidence of GVHD, which offset the
low relapse rate (2/12). For step III, grade III GVHD incidence
was 16/22, TRM 13/22 (8/9 if no GM-CSF) and LFS was 5/22
(all CR patients). The relapse rate was 2/22. In both step II and
III patients, the incidence of CMV reactivation and aspergillosis
was above 50%, probably due to a higher GVHD rate and its
treatment. Patients with CMV reactivation could be treated in a
pre-emptive way by the infusion of ex vivo generated specifi c
T cells, but this was effective only in patients with a mild GVHD
treatment.
Conclusions: none of these three approaches could result in
long-term LFS in patients refractory or progressive. The use
of GM-CSF could maintain some of them leukemia free at the
cost of ultimately lethal GVHD. The use of G-CSF and G-CSF
primed DLI resulted in a low incidence of GVHD and infection,
but was effective in CR patients only. Nevertheless, this could
be the approach of choice for patients in any CR, but we do
not have enough evidence for this,given the low number of CR
patients in this series. The overall LFS for the patients in any
CR was 39% at 9 years, which compares favorably with MUD
transplant and is thus a reasonable alternative for patients in
CR at need of a transplant.

Abstract Number: P1214

Conference Year: 2011

Link to conference website: NULL

New link: NULL

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