SAA Immunosuppressive treatment

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A Joint Protocol of the EBMT Solid Tumors
Working Party and GITMO Group (STWP
-
04)


A PHASE III RANDOMIZED CLINICAL TRIAL OF HIGH
DOSE CHEMOTHERAPY (HDCT) WITH HEMATOPOIETIC
STEM CELL SUPPORT IN WOMEN WITH METASTATIC
BREAST CANCER ACHIEVING A PARTIAL RESPONSE
(PR) TO CONVENTIONAL STANDARD DOSE
CHEMOTHERAPY (SDC).




Principal Investigator Aglietta,
M., MD (Italy)

Co
-
principal Investigator Montemurro,
Filippo (Italy)

I.R.C.C.

Institute for Cancer Research and Treatment

Candiolo, Turi
n
-
Italy

Division of Medical Oncology and Hematology



SOLID TUMORS WORKING PARTY

Chairman T. Demirer



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A Joint Protocol of
The EBMT Solid Tumour Working Party
And The M.D. Anderson Cancer Center
STWP-03 Phase
III Randomized Study of High-Dose
Chemotherapy with Autologous Hematopoietic Stem
Cell Transplantation for Patients with Metastatic
Breast Cancer in Complete Response by Standard
Treatment Principal Investigators Ueno, Naoto
T. nueno_at_mdanderson.org Dept. Blood and Marrow
Transplantation The University of Texas M. D.
Anderson Cancer Center 1515 Holcombe
Blvd, Houston, TX 77030 Hortobagyi, Gabriel N.
ghortoba_at_mdanderson.org Professor and Chairman
of the Department of Breast Medical Oncology
Director of the Breast Cancer Research
Program The University of Texas M. D.
Anderson Cancer Center 1515 Holcombe
Blvd, Houston, TX 77030 Demirer, Taner
ebmt_at_medicine.ankara.edu.tr Professor of
Medicine Chairman of the EBMT Solid Tumour
Working Party Department of Hematology
Ankara University Medical School
06100 Sihhiye, Ankara
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A joint protocol of the EBMT Solid Tumor Working
party
and French National Group


Phase II study of intra
-
familial allogeneic stem cell
transplantation for patients suffering from
metastatic
renal cell carcinoma




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SYNOPSIS
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• Conditioning regimen reduced intensity
  preparative regimen associating
• 1) Cyclophosphamide 60 mg/kg/day for 2
  consecutive days (day -7 and -6)
• 2) Fludarabine 25mg/m²/day for 5 consecutive
  days (day -5 to -1)
• 3) In case of a mismatch on 1 antigen between
  patient and donor, one infusion of Thymoglobulin
  (2.5 mg/kg) will be performed on day -3
• Post graft immunosuppression
• Cyclosporin A starting on day (-2)
• Stem cell harvest and infusion
• Donor will be treated with Neupogen to mobilize
  stem cells. A minimum of 6 x 106 CD34 cells will
  be searched. A maximum of 4 apheresis is allowed
  with a maximum of 7 days of treatment with
  Neupogen . If harvest is inferior to 2 x 106
  CD34 cells, a bone marrow harvest may be
  considered. If harvested cells are between 2 and
  6 x 106 CD34 cells, graft will be infused
  without complement.
• Donor lymphocyte harvest and infusion
• DLI may be used according to
• 1) tumoral response
• 2) chimerism status

ALLOGENEIC STEM CELL TRANSPLANTATION PROCEDURE
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STWP RETROSPECTIVE STUDIES

• Allogeneic transplantation for metastatic breast
  cancer collaborative study EBMT/IBMTR
  (IBMTR/ABMTR 99-01)
• Study chair Dr. Naoto Ueno
• E-mail nueno_at_notes.mdacc.tmc.edu
• Study Co-chair Prof. Dietger Niederwieser
• E-mail dietger_at_medizin.uni-leipzig.de
• EBMT retrospective study on high-dose
  chemotherapy for adult soft tissues sarcoma
• Study chair Prof. Massimo Aglietta
• E-mail maglietta_at_mauriziano.it
• EBMT retrospective study on CNS tumors
• Study chair Dr. Marcus Stockschlaeder
• E-mail stocksch_at_mail.uni-greifswald.de
• EBMT retrospective study on female germ cell
  tumors
• Study chair Dr. Luca Castagna
• E-mail luca.castagna_at_humanitas.it

• Retrospective study on Neuroblastoma
• Study chair Dr. Pierre Biron
• E-mail biron_at_lyon.fnclcc.fr
• Retrospective study on Glioblastoma
• Study chair Dr. Pierre Biron
• E-mail biron_at_lyon.fnclcc.fr
• Retrospective study on Ewings Sarcoma
• Study chair Dr. Amelia Tienghi
• E-mail atienghi_at_libero.it
• Retrospective study on Soft Tissue Sarcoma
• Study chair Dr. Georg Maschmeyer
• E-mail maschmeyer_at_rrk-berlin.de
• Retrospective study on Oligodendroglioma
• Study chair Dr. P. Colombat
• E-mail Colombat_at_med.univ-tours.fr