EBMT NEWSLETTER | September 2013 | Volume 37 - Issue 2

Important dates

The Effect of 2nd generation TKI on the outcome after allogeneic SCT for Patients with CML: A Non-Interventional Prospective Study

Patient Inclusion closes October 1st, 2013
As the study is nearing its recruitment target of 390 patients, it has been decided to close the study for patient inclusion per  01 October 2013.

What does this mean?
- eligible patients of participating centres who receive their allogeneic transplant after 01 October 2013    cannot enter the study.
- eligible patients of participating centres who receive their allogeneic transplant before 01 October 2013 should still be registered in the study.
It is mandatory for participating centres to register all their consecutive eligible patients in the study.
Therefore we urge all participating centres to verify whether all their eligible patients
from 01 January 2010 onwards have been registered in the study.

Participating centres will have until 31 December 2013 to register their eligible patients from the study period. Patient registration forms should be sent to the data office as soon as possible; study data can be submitted at a later point in time during the study.

Patient inclusion criteria
All adult patients with chronic myeloid leukemia in any phase (chronic, accelerated or blastic) who undergo any type of allogeneic stem cell transplantation and have been previously treated with Nilotinib or Dasatinib, regardless of their response to this TKI.

Study period
Eligible patients received their allogeneic transplant between 01 January 2010 and 30 September 2013.

For more information about the study, please contact Jennifer Hoek, study coordinator at the EBMT Data Office in Leiden, via j.d.c.hoek@lumc.nl

Call for data

The chart below shows that although most patients have been registered in the database, the submission of MED B/C and follow up data for this study is not up to expectation. Therefore we want to ask all participants to update their patients in the study at the earliest convenience, and…
Please, do not forget to send in your patients’ MED C form!

We would like to thank all participants for their ongoing cooperation in this important study!

CML subcommittee of the CMWP.

Pre-Transplant Prognostic Factors in Patients with untreated MDS and CMML undergoing Allogeneic Stem Cell Transplantation

The MDS subcommittee of the Chronic Malignancies Working Party (MDS-CMWP) is conducting a non-interventional prospective study on pre-transplant prognostic factors including transfusion dependency and iron toxicity in adult patients with MDS and CMML, undergoing an allogeneic stem cell transplantation. Only patients without previous intensive treatment are included.

We would like to thank all the participating centres for their contribution in this important study.

Since February 1st, 2013 the study has been closed for new patient inclusions and we are collecting currently follow-up information (up to 2 years). Please, check if you have sent in all your eligible patients and please, send us the complete follow-up forms in time so this study can be closed within less than 2 years. After collecting sufficient data we can start the analysis of this first prospective observational study on transfusion dependency and iron toxicity in MDS and CMML patients. Since the planned follow-up is 2 years after SCT we expect to perform the first full analysis in the first quarter of 2015.

In case of any question please contact the EBMT Data Office in Leiden.

HSCT for AML in remission : comparison of iv Bu/Cy vs TBI/Cy regimen: A report from the ALWP of the EBMT

Total body Irradiation associated to cyclophosphamide (TBI/CY) or intravenous (iv) Busulfan/Cy (ivBu/Cy) are the most common myeloablative regimens used in allogeneic hematopoietic stem cell transplantation (allo-HSCT) for adults with acute myelogenous meukemia (AML). However comparative studies of outcomes using ivBU have not been performed. With this aim, we performed a retrospective registry-based study comparing outcomes after allo-HSCT in AML patients given ivBu/Cy (n=795) with those given TBI/Cy (n=864).

Both groups were comparable in terms of age, disease status at transplant, WBC at diagnosis; and type of donor. Engraftment rate was 98% and 99% in the ivBu/Cy and TBI/Cy groups,respectively. Acute graft-versus host disease (GVHD) II-IV was significantly lower in the ivBu/Cy compared to the TBI/Cy group (P<0.0001).

Similarly, chronic GVHD was significantly lower in the iv Bu/Cy compared to the TBI/Cy group (p=0.003). Cumulative incidence of 2-years non-relapse mortality (NRM) was 12+1% in ivBU/CY and 15±2% in TBI/CY groups (p=0.14) and 2years-relapse incidences (RI) were 26±3% and 21±1%, respectively (p=0.012). Leukemia free survival (LFS) rates were 61±2% after ivBU/CY and 64±2% after TBI/CY (p=0.27). In multivariable analysis adjusting for differences between both groups, patients given ivBU/CY had lower chronic GVHD,higher RI and a trend for a lower. At the end, LFS was not statistically different between the two conditioning.

In conclusion, in this retrospective study, final outcomes after myeloablative conditioning regimen using ivBU/CY were not statistically different of TBI/CY.

JCO 2013 in press
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