Bone Marrow Transplantation, (1998) 21, 1–7
Ó 1998 Stockton Press All rights reserved 0268–3369/98 $12.00
Special report
Allogeneic and autologous transplantation for haematological diseases,
solid tumours and immune disorders: current practice in Europe in
1998
JM Goldman1, N Schmitz2, D Niethammer3 and A Gratwohl4 for the Accreditation Sub-Committee
of the European Group for Blood and Marrow Transplantation
1Imperial College School of Medicine, London, UK; 2Christian-Albrechts Universitat, Kiel, Germany; 3University Hospital Tubingen,
Tubingen, Germany; and 4Kantonsspital Basel, Basel, Switzerland
Summary:
In 1996, the Accreditation Sub-Committee of the EBMT
published a special report summarising current practice
in Europe in relation to haemopoietic stem cell trans-
plants for haematological diseases, solid tumours and
immune disorders. An updated report is presented here.
The major change has been the recognition that trans-
plant practice is appreciably different between children
and adults, who should therefore be considered in sep-
arate categories. The autoimmune disorders for which
autografting may be useful are now specified. Non-CML
myeloproliferative disorders and AL amyloidosis have
been added to the list of indications for transplant pro-
cedures in adults. Other changes have been incorpor-
ated into the revised tables.
Keywords: marrow transplantation; indications; rec-
ommendations; practice; Europe
In 1996, the Accreditation Sub-Committee of EBMT pub-
lished a special report in which an attempt was made to
classify allogeneic (allo) and autologous (auto) haemopoi-
etic stem cell transplant (SCT) procedures in accordance
with prevailing practice in Europe.1 The published table
categorised haemopoietic stem cell transplant (HSCT) pro-
cedures by patient diagnosis, stage of disease, patient age
and source of stem cells. Procedures involving predomi-
nantly adults and those involving children were classified
in the same table. Since the 1996 publication, some new
indications for transplant procedures have been recognised
and certain existing indications have been modified. It was
also felt that the usefulness of the classification would be
increased if the issues were addressed separately in adults
and children. The updated classification is reproduced
below.
Many details of the classifications contained in this
Correspondence: Prof JM Goldman, Haematology Department, Imperial
College School of Medicine at the Hammersmith Hospital, Du Cane Road,
London W12 0NN, UK
Received 18 October 1997; accepted 20 October 1997
report may be regarded as controversial. It was not our
intention in this report to review the literature in detail nor
to provide reasoned arguments for and against the decision
to offer a given patient a transplant in a given clinical situ-
ation. Rather we have attempted to summarise the opinions
and practice of clinicians working in transplant centres in
Europe in 1998.1,2
Patient age
The age of an individual patient remains one of the most
important determinants of outcome following both allo-
geneic and autologous HSCT procedures. As a broad gener-
alisation it seems reasonable to recommend limits of 65
years for autograft procedures, of 60 years for allograft pro-
cedures using HLA-identical sibling donors and of 45 years
for unrelated donor transplants. There will always be cases
where it is reasonable to exceed these arbitrary limits. (For
the purposes of this document, patients up to the age of 16
years are classified as children.)
Categorisation of transplant procedures
The categories into which different transplant procedures
were allocated were defined in the 1996 publication and
have given rise to some discussion subsequently. These cat-
egories are recapitulated with some modifications below:
1. Routine (R): Transplants categorised as routine are car-
ried out in many centres in Europe, often without entering
the patient into an institutional or national study. The
results of such transplants are in general reasonably well
defined and compare favourably (or are superior to) results
of non-transplant treatment approaches. The term ‘stan-
dard’ has been proposed in place of ‘routine’ but ‘routine’
has been retained. Obviously defining a transplant as ‘rou-
tine’ does not mean that it is necessarily the optimal therapy
for a given patient in all clinical circumstances. ‘Routine’
transplants may be performed in any specialist centre with
experience with HSCT procedures provided they have an
appropriate infrastructure as defined by EBMT guidelines.3

Current practice in Europe
JM Goldman et al
2 2. Clinical Research Protocol (CRP): The value of trans-
plants for patients in these categories is not yet clearly
established. Candidate patients are therefore offered the
opportunity of undergoing allo- or auto-SCT in the context
of a clinical research protocol that has been designed
specifically to cover a series of patients who satisfy defined
diagnostic criteria. The protocol may have been written for
a single institution or may reflect national or international
multi-centre collaboration. The protocol will usually have
been approved by a Research Ethics Committee or an Insti-
tutional Review Board. It is implied that the results of the
study are intended for presentation to and/or publication for
the medical community at large. It should be stressed that
the CRP may or may not be a randomised comparison of
two or more approaches to treatment.
3. Developmental (D): Transplants have been classified as
developmental if there is little or no national or inter-
national experience with this particular type of transplant.
In general such transplants will involve single cases or
small pilot series undertaken by transplant units with
acknowledged special expertise in the management of that
particular disease. The category also covers fundamentally
new approaches to the management of a disease which in
a different status or phase may already be classified under
(R) or (CRP) above. Protocols for ‘D’ transplants will usu-
ally have been approved by local Research Ethics Commit-
tees. Again, it is implied that the results of ‘D’ transplants
are intended for presentation or publication.
4. Not generally recommended (NR): This category covers
procedures contemplated for a disease in a phase or status
in which patients are not conventionally treated by haemo-
poietic SCT. Clearly there will be some overlap between
‘NR’ and ‘D’. It also includes early disease stages when
results of conventional treatment do not justify the
additional risk of transplant-related mortality, or when the
disease is so advanced that the chance of success is so small
that the risk of the harvest procedure for the normal donor
is difficult to justify. ‘NR’ may not apply to specific situ-
ations where there exists a syngeneic donor.
Status of transplants in specific diseases in adults
The updated classification of SCT procedures in adults is
shown in Table 1. The principal changes include a revised
classification of the lymphomas and the myelodysplastic
syndromes. The autoimmune disorders that may be con-
sidered for autografting are specified separately. The use of
autografting for AL amyloidosis is being studied in special-
ist centres and is therefore included in Table 1. An abbrevi-
ated version of the text published in 19961 with appropriate
modifications appears below:
1. Acute myeloid leukaemia (AML)
Patients with AML in first remission may be treated by
allo- or auto-SCT on an individual basis or within the con-
text of a clinical study. Patients who fail to achieve com-
plete remission after two courses of induction chemo-
therapy may be treated by allo-BMT with an HLA-identical
sibling, or if time permits, by allo-BMT from a matched
unrelated donor. Patients with AML in early relapse or in
second or later remission may also be treated by allo-SCT.
Patients in established relapse are not generally rec-
ommended for allo-SCT. Transplants involving unrelated
donors for AML in remission should proceed largely in the
context of a clinical research protocol.
Patients with AML in first remission, early relapse or
later remission may be treated by auto-SCT with or without
purging of harvested marrow.
The results of transplant procedures for AML must
always be compared with results of contemporary chemo-
therapy regimens; some groups discourage allograft pro-
cedures for patients in first remission with cytogenetically
‘favourable’ sub-types of AML.
2. Acute lymphoblastic leukaemia (ALL)
Selected patients with ALL, especially those with poor
prognostic features (eg adults, patients of any age with Phil-
adelphia chromosome-positive ALL), are currently con-
sidered for treatment by allogeneic BMT in first remission
if they have a sibling donor; autografting may be a reason-
able alternative. Both procedures can be performed on an
ad personam basis or in the context of a clinical research
protocol. The same stipulations apply to a patient with stan-
dard risk ALL treated with chemotherapy only in first
remission who relapses and then is restored to second
remission with further chemotherapy. As with AML, ALL
patients who fail to achieve complete remission after two
courses of induction chemotherapy may be treated by allo-
BMT with an HLA-identical sibling, or if time permits, by
allo-BMT from a matched unrelated donor.
3. Chronic myeloid leukaemia (CML)
Patients with CML under the age of 60 may be treated by
allogeneic BMT with marrow from sibling donors on a rou-
tine basis. The transplant should ideally be performed in
chronic phase within 1 year from diagnosis but patients in
advanced phases may also be offered transplants on an indi-
vidual basis. The timing of transplant for patients with com-
patible donors who achieve a major or complete cyto-
genetic response to interferon-a remains uncertain.
Transplants using unrelated donors are usually undertaken
in the context of clinical research protocols. Autografts for
patients in chronic phase up to age 65 years may be perfor-
med for selected patients within approved clinical research
protocols; autografts for patients with advanced disease
may be performed in selected cases within the clinical
trial setting.
4. Myeloproliferative disorders other than CML
There is little experience with the use of either allo- or
auto-SCT in the management of patients with primary poly-
cythaemia, essential thrombocythaemia or primary myelo-
fibrosis. It would seem reasonable however that any patient
in this category with ‘high-risk’ disease who has an HLA-
identical sibling could be considered for allografting in a