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

NCT ID: NCT01020175

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-01-31

Study Completion Date

2002-12-31

Brief Summary

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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

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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

Conditions

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Acute Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome

Keywords

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allogeneic transplantation Leukemia GvHD MDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone marrow transplantation

Patients received bone marrow transplantation

Group Type OTHER

Bone marrow transplantation

Intervention Type PROCEDURE

Patients received bone marrow transplantation

Peripheral blood stem cell transplantation

Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Group Type OTHER

Peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Interventions

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Bone marrow transplantation

Patients received bone marrow transplantation

Intervention Type PROCEDURE

Peripheral blood stem cell transplantation

Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

European Society for Blood and Marrow Transplantation

NETWORK

Sponsor Role lead

Responsible Party

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EBMT

Principal Investigators

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Nobert Schmitz, Prof.

Role: STUDY_CHAIR

Christian-Albrechts- Universita¨t, Kiel, Germany

H Greinix, Dr

Role: PRINCIPAL_INVESTIGATOR

Allgemeines Krankenhaus, Vienna, Austria

D Niederwieser, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital Innsbruck, Austria

M. Boogaerts, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Leuven, Belgium

A Ferrant, Dr

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires St Luc, Brussels, Belgium

R. Arnold, Dr.

Role: PRINCIPAL_INVESTIGATOR

Charite der Humboldt Universität, Berlin, Germany

E Gluckman, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hopital St Louis, Paris, France

N C Gorin, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hoˆpital St Antoine, Paris, France

N Frickhofen, Dr

Role: PRINCIPAL_INVESTIGATOR

Universita¨t Ulm, Germany

P Dreger, Dr.

Role: PRINCIPAL_INVESTIGATOR

Christian-Albrechts- Universita¨t, Kiel, Germany

A Zander, Dr

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Eppendorf, Hamburg, Germany

S McCann, Dr.

Role: PRINCIPAL_INVESTIGATOR

St James Hospital, Dublin, Ireland

A Nagler, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital, Jerusalem, Israel

A Bacigalupo, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Martino, Genova, Italy

A Gratwohl, Dr.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital, Basel, Switzerland

J Apperley, Prof.

Role: PRINCIPAL_INVESTIGATOR

Hammersmith Hospital, London, United Kingdom

N H Russell, Dr.

Role: PRINCIPAL_INVESTIGATOR

Nottingham City Hospital, United Kingdom

O Ringde´n, Dr.

Role: PRINCIPAL_INVESTIGATOR

Huddinge Hospital, Sweden

I Majolino, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ospedale V Cervello-USL, Palermo, Italy

J P Jouet, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hopital Claude Huriez, Lille, France

B Varet, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hopital Necker, Paris, France

J Finke, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Albert-Ludwigs-Universität, Freiburg, Germany

G. Smith, Dr.

Role: PRINCIPAL_INVESTIGATOR

Leeds General Infirmary, United Kingdom

A Bosi, Dr.

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Careggi, Firenze, Italy

G Lambertenghi-Deliliers, Dr.

Role: PRINCIPAL_INVESTIGATOR

Padiglione G Marcora, Ospedale Maggiore di Milano, Italy

K Kolbe, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitatsklinikum, Mainz, Germany

T Ruutu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Helsinki University CT. Rentral Hospital, Finland

K A Bradstock), Dr.

Role: PRINCIPAL_INVESTIGATOR

Westmead Hospital, Australia

B Lioure, Dr.

Role: PRINCIPAL_INVESTIGATOR

LCHRU de Hautepierre, Strasbourg, France

T Hughes, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hanson Centre for Cancer Research, Royal Adelaide Hospital, Australia

J Szer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Royal Melbourne Hospital, Parkville, Australia

R Herrmann, Dr.

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital, Australia

L Tru¨mper, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik, Homburg, Germany

M Falda, Dr.

Role: PRINCIPAL_INVESTIGATOR

Centro Dipartimentale Trapianti di Midollo, Ospedale Molinette, Torino, Italy

M Beksac, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ankara University Medical Facility, Turkey

E Nikiforakis, Dr.

Role: PRINCIPAL_INVESTIGATOR

Evangelismos General Hospital, Athens, Greece

M Abecasis, Dr.

Role: PRINCIPAL_INVESTIGATOR

Instituto Portugues de Oncologia Francisco Gentil, Lisboa, Portugal

J Rowe, Dr.

Role: PRINCIPAL_INVESTIGATOR

Rambam Medical Center, Haifa, Israel

M Potter, Dr.

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital Hampstead, London, United Kingdom

H Wandt, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik Nurnberg, Germany

R Schwerdtfeger, Dr.

Role: PRINCIPAL_INVESTIGATOR

Stiftung Deutsche Klinik f. Diagnostik, Wiesbaden, Germany

J Casper, Dr

Role: PRINCIPAL_INVESTIGATOR

University Rostock, Germany

A. Pagliuca, Dr.

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital, London, United Kingdom

Locations

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Dr. Norbert Schmitz

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Friedrichs B, Tichelli A, Bacigalupo A, Russell NH, Ruutu T, Shapira MY, Beksac M, Hasenclever D, Socie G, Schmitz N. Long-term outcome and late effects in patients transplanted with mobilised blood or bone marrow: a randomised trial. Lancet Oncol. 2010 Apr;11(4):331-8. doi: 10.1016/S1470-2045(09)70352-3. Epub 2010 Jan 30.

Reference Type DERIVED
PMID: 20117965 (View on PubMed)

Other Identifiers

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GCSF-940136

Identifier Type: -

Identifier Source: org_study_id