Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation

This study has been completed.
Sponsor:
Collaborators:
Amgen
Hoffmann-La Roche
Information provided by:
European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier:
NCT01020175
First received: November 23, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndrome
Procedure: Bone marrow transplantation
Procedure: Peripheral blood stem cell transplantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by European Group for Blood and Marrow Transplantation:

Primary Outcome Measures:
  • The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute GVH disease grade II or above [ Designated as safety issue: No ]
  • Time to acute GVH disease [ Designated as safety issue: No ]
  • Time to an unsupported platelet count of 20 _ 109/L and 50 _ 109/L [ Designated as safety issue: No ]
  • Time to absolute neutrophil count (ANC) of 0.5 x 10e9/L and 1 x 10e9/L [ Designated as safety issue: No ]
  • Incidence and severity of chronic GVH disease [ Designated as safety issue: No ]
  • Leukemia-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: January 1995
Study Completion Date: December 2002
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bone marrow transplantation
Patients received bone marrow transplantation
Procedure: Bone marrow transplantation
Patients received bone marrow transplantation
Peripheral blood stem cell transplantation
Patients received filgrastim-mobilized peripheral blood stem cell transplantation
Procedure: Peripheral blood stem cell transplantation
Patients received filgrastim-mobilized peripheral blood stem cell transplantation

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with either diagnosis of AML in first or second remission, in first untreated relapse (blast count in marrow < 30%); ALL in first or second remission, in first untreated relapse (blast count in marrow < 30%); CML in first chronic phase, in first accelerated phase (total blast and promyelocytes in marrow and or peripheral blood < 30%) or MDS (excluding RAEB-t).
  • Age between 18 and 55 years.
  • ECOG performance status between 0,1 or 2.
  • HLA-identical sibling donor.
  • Written informed consent.

Exclusion Criteria:

  • Serum creatinine more than 10% above the normal range for the centre.
  • Left ventricular size and function abnormal.
  • DLCO < 50%.
  • Bilirubin > 2mg/dL (34.2 µmol/L).
  • Splenectomised or splenic irradiation.
  • Psychiatric, addictive, or any other disorder, which compromises ability to give truly informed consent for participation in this study.
  • Currently receiving non-licensed drugs which may affect GVHD or engraftment.
  • Pregnant or lactating women.
  • Known sensitivity to E.coli derived products.
  • HIV positive.
  • Previously received BM/PBPC transplant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020175

Locations
Germany
Dr. Norbert Schmitz
Hamburg, Germany, 20099
Sponsors and Collaborators
European Group for Blood and Marrow Transplantation
Amgen
Hoffmann-La Roche
Investigators
Study Chair: Nobert Schmitz, Prof. Christian-Albrechts- Universita¨t, Kiel, Germany
Principal Investigator: H Greinix, Dr Allgemeines Krankenhaus, Vienna, Austria
Principal Investigator: D Niederwieser, Dr University Hospital, Innsbruck, Austria
Principal Investigator: M. Boogaerts, Dr. University Hospital, Leuven, Belgium
Principal Investigator: A Ferrant, Dr Cliniques Universitaires St Luc, Brussels, Belgium
Principal Investigator: R. Arnold, Dr. Charite der Humboldt Universität, Berlin, Germany
Principal Investigator: E Gluckman, Dr. Hopital St Louis, Paris, France
Principal Investigator: N C Gorin, Dr. Hoˆpital St Antoine, Paris, France
Principal Investigator: N Frickhofen, Dr Universita¨t Ulm, Germany
Principal Investigator: P Dreger, Dr. Christian-Albrechts- Universita¨t, Kiel, Germany
Principal Investigator: A Zander, Dr Universitätsklinikum Eppendorf, Hamburg, Germany
Principal Investigator: S McCann, Dr. St James Hospital, Dublin, Ireland
Principal Investigator: A Nagler, Dr. Hadassah University Hospital, Jerusalem, Israel
Principal Investigator: A Bacigalupo, Dr. Ospedale San Martino, Genova, Italy
Principal Investigator: A Gratwohl, Dr. Kantonsspital, Basel, Switzerland
Principal Investigator: J Apperley, Prof. Hammersmith Hospital, London, United Kingdom
Principal Investigator: N H Russell, Dr. Nottingham City Hospital, United Kingdom
Principal Investigator: O Ringde´n, Dr. Huddinge Hospital, Sweden
Principal Investigator: I Majolino, Dr. Ospedale V Cervello-USL, Palermo, Italy
Principal Investigator: J P Jouet, Dr. Hopital Claude Huriez, Lille, France
Principal Investigator: B Varet, Dr. Hopital Necker, Paris, France
Principal Investigator: J Finke, Dr. Klinikum der Albert-Ludwigs-Universität, Freiburg, Germany
Principal Investigator: G. Smith, Dr. Leeds General Infirmary, United Kingdom
Principal Investigator: A Bosi, Dr. Azienda Ospedaliera Careggi, Firenze, Italy
Principal Investigator: G Lambertenghi-Deliliers, Dr. Padiglione G Marcora, Ospedale Maggiore di Milano, Italy
Principal Investigator: K Kolbe, Dr. Universitatsklinikum, Mainz, Germany
Principal Investigator: T Ruutu, Dr. Helsinki University CT. Rentral Hospital, Finland
Principal Investigator: K A Bradstock), Dr. Westmead Hospital, Australia
Principal Investigator: B Lioure, Dr. LCHRU de Hautepierre, Strasbourg, France
Principal Investigator: T Hughes, Dr. Hanson Centre for Cancer Research, Royal Adelaide Hospital, Australia
Principal Investigator: J Szer, Dr. Royal Melbourne Hospital, Parkville, Australia
Principal Investigator: R Herrmann, Dr. Royal Perth Hospital, Australia
Principal Investigator: L Tru¨mper, Dr. Universitätsklinik, Homburg, Germany
Principal Investigator: M Falda, Dr. Centro Dipartimentale Trapianti di Midollo, Ospedale Molinette, Torino, Italy
Principal Investigator: M Beksac, Dr. Ankara University Medical Facility, Turkey
Principal Investigator: E Nikiforakis, Dr. Evangelismos General Hospital, Athens, Greece
Principal Investigator: M Abecasis, Dr. Instituto Portugues de Oncologia Francisco Gentil, Lisboa, Portugal
Principal Investigator: J Rowe, Dr. Rambam Medical Center, Haifa, Israel
Principal Investigator: M Potter, Dr. Royal Free Hospital Hampstead, London, United Kingdom
Principal Investigator: H Wandt, Dr. Medizinische Klinik Nurnberg, Germany
Principal Investigator: R Schwerdtfeger, Dr. Stiftung Deutsche Klinik f. Diagnostik, Wiesbaden, Germany
Principal Investigator: J Casper, Dr University Rostock, Germany
Principal Investigator: A. Pagliuca, Dr. King's College Hospital, London, United Kingdom
  More Information

Additional Information:
No publications provided by European Group for Blood and Marrow Transplantation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EBMT
ClinicalTrials.gov Identifier: NCT01020175     History of Changes
Other Study ID Numbers: GCSF-940136
Study First Received: November 23, 2009
Last Updated: November 23, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by European Group for Blood and Marrow Transplantation:
allogeneic transplantation
Leukemia
GvHD
MDS

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia
Acute Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myelodysplastic Syndromes
Preleukemia
Syndrome
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease

ClinicalTrials.gov processed this record on September 16, 2014