Spots Global Cancer Trial Database for Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation
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Trial Identification
Brief Title: Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation
Official Title: A Phase III, Randomized, Multicentre Trial Comparing Allogeneic Filgrastim Mobilised Peripheral Blood Progenitor Cell Transplantation (PBPCT) With Allogeneic Bone Marrow Transplantation (BMT) in Patients With Acute Leukemia, Chronic Myelogenous Leukemia or Myelodysplastic Syndrome
Study ID: NCT01020175
Study Description
Brief Summary: 350 patients with early leukemias were assigned to receive peripheral blood or bone marrow transplantation; the occurrence of acute and chronic graft versus host disease, survival, transplantation-related mortality, and relapse rates were compared.
Detailed Description: The trial was designed to investigate the safety and outcome of allogeneic filgrastim-mobilized PBPCT compared with allogeneic BMT in patients with standard-risk leukemia. A total of 350 patients between 18 and 55 years of age with acute leukemias in remission or chronic myelogenous leukemia in first chronic phase were randomized to receive either filgrastim-mobilized peripheral blood progenitor cells or bone marrow cells from HLA-identical sibling donors after standard high-dose chemoradiotherapy. The study was approved by the ethics committees of all participating centers, and all patients and donors gave informed consent before any study-related procedure was performed. Donor-recipient pairs were randomized to undergo either BMT or PBPCT. Randomization was carried out centrally at the International Institute for Drug Development (id2), Brussels, Belgium, and used the minimization method to allocate donor and recipient to allogeneic BMT or PBPCT. The randomization strata were as follows: diagnosis (chronic myeloid leukemia \[CML\] vs other diseases), sex mismatch of donor and recipient, and whether the donor was female and nulliparous. Follow-up visits were scheduled for 6, 12, 24, and 36 months after the date of transplantation. Neutrophil and platelet recovery occurred significantly faster after transplantation of peripheral blood progenitor cells than after bone marrow transplantation. Acute graft versus host disease of grades II-IV was significantly more frequent in recipients of peripheral blood progenitor cells than in recipients of marrow cells The cumulative incidence of chronic graft versus host disease was higher with peripheral blood progenitor cells than with bone marrow cells
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dr. Norbert Schmitz, Hamburg, , Germany
Contact Details
Name: Nobert Schmitz, Prof.
Affiliation: Christian-Albrechts- Universita¨t, Kiel, Germany
Role: STUDY_CHAIR
Name: H Greinix, Dr
Affiliation: Allgemeines Krankenhaus, Vienna, Austria
Role: PRINCIPAL_INVESTIGATOR
Name: D Niederwieser, Dr
Affiliation: University Hospital Innsbruck, Austria
Role: PRINCIPAL_INVESTIGATOR
Name: M. Boogaerts, Dr.
Affiliation: University Hospital, Leuven, Belgium
Role: PRINCIPAL_INVESTIGATOR
Name: A Ferrant, Dr
Affiliation: Cliniques Universitaires St Luc, Brussels, Belgium
Role: PRINCIPAL_INVESTIGATOR
Name: R. Arnold, Dr.
Affiliation: Charite der Humboldt Universität, Berlin, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: E Gluckman, Dr.
Affiliation: Hopital St Louis, Paris, France
Role: PRINCIPAL_INVESTIGATOR
Name: N C Gorin, Dr.
Affiliation: Hoˆpital St Antoine, Paris, France
Role: PRINCIPAL_INVESTIGATOR
Name: N Frickhofen, Dr
Affiliation: Universita¨t Ulm, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: P Dreger, Dr.
Affiliation: Christian-Albrechts- Universita¨t, Kiel, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: A Zander, Dr
Affiliation: Universitätsklinikum Eppendorf, Hamburg, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: S McCann, Dr.
Affiliation: St James Hospital, Dublin, Ireland
Role: PRINCIPAL_INVESTIGATOR
Name: A Nagler, Dr.
Affiliation: Hadassah University Hospital, Jerusalem, Israel
Role: PRINCIPAL_INVESTIGATOR
Name: A Bacigalupo, Dr.
Affiliation: Ospedale San Martino, Genova, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: A Gratwohl, Dr.
Affiliation: Kantonsspital, Basel, Switzerland
Role: PRINCIPAL_INVESTIGATOR
Name: J Apperley, Prof.
Affiliation: Hammersmith Hospital, London, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
Name: N H Russell, Dr.
Affiliation: Nottingham City Hospital, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
Name: O Ringde´n, Dr.
Affiliation: Huddinge Hospital, Sweden
Role: PRINCIPAL_INVESTIGATOR
Name: I Majolino, Dr.
Affiliation: Ospedale V Cervello-USL, Palermo, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: J P Jouet, Dr.
Affiliation: Hopital Claude Huriez, Lille, France
Role: PRINCIPAL_INVESTIGATOR
Name: B Varet, Dr.
Affiliation: Hopital Necker, Paris, France
Role: PRINCIPAL_INVESTIGATOR
Name: J Finke, Dr.
Affiliation: Klinikum der Albert-Ludwigs-Universität, Freiburg, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: G. Smith, Dr.
Affiliation: Leeds General Infirmary, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
Name: A Bosi, Dr.
Affiliation: Azienda Ospedaliera Careggi, Firenze, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: G Lambertenghi-Deliliers, Dr.
Affiliation: Padiglione G Marcora, Ospedale Maggiore di Milano, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: K Kolbe, Dr.
Affiliation: Universitatsklinikum, Mainz, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: T Ruutu, Dr.
Affiliation: Helsinki University CT. Rentral Hospital, Finland
Role: PRINCIPAL_INVESTIGATOR
Name: K A Bradstock), Dr.
Affiliation: Westmead Hospital, Australia
Role: PRINCIPAL_INVESTIGATOR
Name: B Lioure, Dr.
Affiliation: LCHRU de Hautepierre, Strasbourg, France
Role: PRINCIPAL_INVESTIGATOR
Name: T Hughes, Dr.
Affiliation: Hanson Centre for Cancer Research, Royal Adelaide Hospital, Australia
Role: PRINCIPAL_INVESTIGATOR
Name: J Szer, Dr.
Affiliation: Royal Melbourne Hospital, Parkville, Australia
Role: PRINCIPAL_INVESTIGATOR
Name: R Herrmann, Dr.
Affiliation: Royal Perth Hospital, Australia
Role: PRINCIPAL_INVESTIGATOR
Name: L Tru¨mper, Dr.
Affiliation: Universitätsklinik, Homburg, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: M Falda, Dr.
Affiliation: Centro Dipartimentale Trapianti di Midollo, Ospedale Molinette, Torino, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: M Beksac, Dr.
Affiliation: Ankara University Medical Facility, Turkey
Role: PRINCIPAL_INVESTIGATOR
Name: E Nikiforakis, Dr.
Affiliation: Evangelismos General Hospital, Athens, Greece
Role: PRINCIPAL_INVESTIGATOR
Name: M Abecasis, Dr.
Affiliation: Instituto Portugues de Oncologia Francisco Gentil, Lisboa, Portugal
Role: PRINCIPAL_INVESTIGATOR
Name: J Rowe, Dr.
Affiliation: Rambam Medical Center, Haifa, Israel
Role: PRINCIPAL_INVESTIGATOR
Name: M Potter, Dr.
Affiliation: Royal Free Hospital Hampstead, London, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
Name: H Wandt, Dr.
Affiliation: Medizinische Klinik Nurnberg, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: R Schwerdtfeger, Dr.
Affiliation: Stiftung Deutsche Klinik f. Diagnostik, Wiesbaden, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: J Casper, Dr
Affiliation: University Rostock, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: A. Pagliuca, Dr.
Affiliation: King's College Hospital, London, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
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