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

November 23, 2009 updated by: European Society for Blood and Marrow Transplantation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20099
        • Dr. Norbert Schmitz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Bone marrow transplantation
Patients received bone marrow transplantation
Procedure: Bone marrow transplantation
Patients received bone marrow transplantation
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.

Secondary Outcome Measures

Outcome Measure
Overall survival
Incidence of acute GVH disease grade II or above
Time to acute GVH disease
Time to an unsupported platelet count of 20 _ 109/L and 50 _ 109/L
Time to absolute neutrophil count (ANC) of 0.5 x 10e9/L and 1 x 10e9/L
Incidence and severity of chronic GVH disease
Leukemia-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society for Blood and Marrow Transplantation

Collaborators

Hoffmann-La Roche
Amgen

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1995

Primary Completion (ACTUAL)

December 1, 1999

Study Completion (ACTUAL)

December 1, 2002

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (ESTIMATE)

November 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 23, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCSF-940136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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