NCT01020175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 1995

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

4.9 years

First QC Date

November 23, 2009

Last Update Submit

November 23, 2009

Conditions

Acute LeukemiaChronic Myelogenous LeukemiaMyelodysplastic Syndrome

Keywords

allogeneic transplantationLeukemiaGvHDMDS

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Bone marrow transplantation

OTHER

Patients received bone marrow transplantation

Procedure: Bone marrow transplantation

Peripheral blood stem cell transplantation

OTHER

Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Procedure: Peripheral blood stem cell transplantation

Interventions

Bone marrow transplantationPROCEDURE

Patients received bone marrow transplantation

Bone marrow transplantation
Peripheral blood stem cell transplantationPROCEDURE

Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Peripheral blood stem cell transplantation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Norbert Schmitz

Hamburg, 20099, Germany

Location

Related Publications (1)

  • 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.

    PMID: 20117965DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveMyelodysplastic SyndromesLeukemia

Interventions

Bone Marrow TransplantationPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeHematopoietic Stem Cell TransplantationStem Cell TransplantationCell Transplantation

Study Officials

  • Nobert Schmitz, Prof.

    Christian-Albrechts- Universita¨t, Kiel, Germany

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

January 1, 1995

Primary Completion

December 1, 1999

Study Completion

December 1, 2002

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

DE(1)