Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation
This study has been completed.
Sponsor:
European Group for Blood and Marrow Transplantation
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
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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:
MedlinePlus related topics:
Bone Marrow Transplantation
Chronic Myeloid Leukemia
Leukemia
Myelodysplastic Syndromes
Drug Information available for:
Filgrastim
U.S. FDA Resources
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
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 Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia Acute Disease Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013