In this July issue, we would like to give you an overview of four important studies:
The CALM study - Collaboration to Collect Autologous transplant outcomes in Lymphoma and Myeloma patients. The deadline for MED B/C data submission has been extended until September 30, 2013.
Plerixafor Off-label study: as a post-marketing commitment to the EMA, Genzyme is required to monitor the off-label transplant use of plerixafor, using data in the EBMT registry.
The Effect of 2nd generation TKI, on the outcome after allogeneic SCT for patients with CML.This non-interventional prospective study is still recruiting. Patients may be included retrospectively from the start of the study January 1, 2010.
The Role of Donor vs Recipient NK Cell Allo-reactivity in Haploidentical Hematopoietic Transplantation for Hematologic Malignancies.
The CALM study - Collaboration to Collect Autologous transplant outcomes in Lymphoma and Myeloma patients
Call for data!Thank you all for sending in your data the last 2 months, we are on our way but still have a long way to go!! Of the 52 participating centres 46 are sending in data and of the 9500 transplants we are collecting in total, 3000 MED-B and 2600 MED-C forms have been received.
We would like to urge you to please send in your MED B and MED C data as soon as possible.
If you are not performing your own data entry, you are asked to send the MED-B data for the prospective transplantations (not yet registered in ProMISe) to the EBMT Data Office in London.
The MED-B data for the retrospective transplantations (already registered in ProMISe) as well as the MED-C data for all transplantations should be sent to the EBMT Data Office in Leiden.
If you are performing your own data entry, please be reminded to create a working party record in ProMISe and enter the CALM study code 42206644. If you have already entered your patients in Promise please let us know and we can assign the CALM study code for you.
In order to spread the workload, we would like to ask you to send us data on an on-going base.
Extension data submission deadlineThe deadline for MED B/C data submission has been extended until September 30, 2013
CALM study coordinationAs of the 15th of June Cora Knol-Bout has joined EBMT to assist the current study coordinators, Steffie van der Werf and Paul Bosman in their work for the CALM study. Any CALM study related correspondence/questions can be send to Steffie, Paul or Cora via e-mail address: firstname.lastname@example.org.
Plerixafor Off-label studyAs a post-marketing commitment to the EMA, Genzyme is required to monitor the off-label transplant use of plerixafor, using data in the EBMT registry. To survey the usage in off-label settings over a 5 year period (31 July 2009 - 31 July 2014) we are collecting the transplant use indication and the patient identification items on a short MED-C form of only 2 pages. EBMT expects the MED-A data form to be registered at day 100 after transplant as usual.
At present 25 centres have registered for participation and another 8 centres have let us know that they are interested. Thank you for sending in the Centre Registration Form with your estimated number of eligible patients. Of the 200 transplants we are planning to collect we have now received 56 MED-C forms. Therefore, we kindly urge you to send in your MED-C forms. Every centre is welcome to participate in this NIS by sending in MED-C data.
Eligible for the study are patients treated with plerixafor who have one or more of the following: a background disease other than lymphoma or multiple myeloma; < 18 years old; Tx using ex-vivo plerixafor-mobilised cells; treatment with plerixafor alone; contraindication for G-CSF; allo-Tx; Tx using plerixafor-mobilised BM cells; routes of plerixafor administration other than subcutaneous; do NOT have the diagnosis of poor mobilizer; other situations, e.g. plerixiafor first-line use.
For more information about the study, please contact study coordinator Annelies Kleijne at the EBMT Data Office in Leiden, via e-mail address: email@example.com. Information about the study and registration can also be found on the EBMT website (Study 42206645).
The Effect of 2nd generation TKI on the outcome after allogeneic SCT for Patients with CML: A Non-Interventional Prospective StudyThis study is still recruiting. Patients may be included retrospectively from the start of the study at January 1, 2010.
Call for centres and patientsWe are happy to report that at this moment 89 centres have signed up for participation, and 306 patients have already been included in the study.
We aim to include 400 patients by the end of 2013.
It is still possible to register for the study. If your centre has transplanted any CML patient since January 2010 (or is planning to do so), please consider registering your centre.
For more information about the study, please contact Jennifer Hoek, the study coordinator at the EBMT Data Office in Leiden, via firstname.lastname@example.org
Call for dataThe 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!
Study InformationWhile the use of Imatinib prior to stem cell transplantation seems to have no adverse impact on the outcome of allogeneic stem cell transplantation little is known on the impact of prior use of second generation TK inhibitors. Therefore this non-interventional prospective study addresses this question and patients undergoing allogeneic stem cell transplantation after prior use of 2nd generation TKIs will be followed by the EBMT Leiden office on engraftment, treatment related mortality, relapse rate and survival, prospectively. Details on TKI therapy will be collected by the participating centres, retrospectively.
The registry will include patients from 01-01-2010 to 31-12-2013 and there will be 2 years of follow up.
The patient inclusion criteria areAll 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.
We would like to thank all participants for their ongoing cooperation in this important study!
The CML subcommittee of the CMWP
Call for patients for the Non-Interventional Prospective Study on the Role of Donor vs Recipient NK Cell Allo-reactivity in Haploidentical Hematopoietic Transplantation for Hematologic Malignancies.
The Immunobiology Working Party (IWP) is conducting a study to evaluate the role of donor vs recipient NK cell allo-reactivity in haploidentical hematopoietic transplantation for hematologic malignancies. Donor-versus-recipient NK cell allo-reactivity is a key therapeutic element in the success of HLA haplotype mismatched (“haploidentical”) hematopoietic stem cell transplants for acute myeloid leukemia. The role of NK cell allo-reactivity will be assessed separately in T cell depleted and T cell replete transplants in the following two patient populations: 1) AML or ALL in any remission; 2) AML or ALL in chemo-resistant relapse.
Take this opportunity to include your patients in this important study!
The patient inclusion criteria are
We are happy to report that at this moment 11 centres have signed up for participation, and 11 patients have been included in the study. We aim to recruit at least 200 patients with a two year follow up.
Should you have eligible patients for this study, please contact the EBMT Data Office Leiden at email@example.com