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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Society for Blood and Marrow Transplantation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hoffmann-La Roche
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1995

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 1999

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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