Acute LeukemiaPhase 3NCT01020175
Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell Transplantation
A Phase 3 study testing Bone marrow transplantation and Peripheral blood stem cell transplantation in people with Acute Leukemia and Chronic Myelogenous Leukemia, run by European Society for Blood and Marrow Transplantation at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Leukemia, Chronic Myelogenous Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Bone marrow transplantation and Peripheral blood stem cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteGermany
- Study dates
- Jan 1995to Dec 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Bone marrow transplantation, Peripheral blood stem cell transplantation
- Keywords
- allogeneic transplantation, Leukemia, GvHD, MDS
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow transplantationProcedure or surgery
Patients received bone marrow transplantation
Peripheral blood stem cell transplantationProcedure or surgery
Patients received filgrastim-mobilized peripheral blood stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Bone marrow transplantation | Other | Patients received bone marrow transplantation Receives: Procedure: Bone marrow transplantation |
| Peripheral blood stem cell transplantation | Other | Patients received filgrastim-mobilized peripheral blood stem cell transplantation Receives: Procedure: Peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Leukemia-free survival
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJan 1995
- Primary completionDec 1999
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society for Blood and Marrow Transplantation
- Sponsor type
- Research network
- Collaborators
- Amgen, Hoffmann-La Roche
- Investigators
- Nobert Schmitz, Prof., Study chair, Christian-Albrechts- Universita¨t, Kiel, GermanyH Greinix, Dr, Principal investigator, Allgemeines Krankenhaus, Vienna, AustriaD Niederwieser, Dr, Principal investigator, University Hospital Innsbruck, AustriaM. Boogaerts, Dr., Principal investigator, University Hospital, Leuven, BelgiumA Ferrant, Dr, Principal investigator, Cliniques Universitaires St Luc, Brussels, BelgiumR. Arnold, Dr., Principal investigator, Charite der Humboldt Universität, Berlin, GermanyE Gluckman, Dr., Principal investigator, Hopital St Louis, Paris, FranceN C Gorin, Dr., Principal investigator, Hoˆpital St Antoine, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020175
- Sponsor's protocol ID
- GCSF-940136
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20117965
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01020175
- Acronym / sponsor ID
- GCSF-940136
- Keywords
- allogeneic transplantation, Leukemia, GvHD, MDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- European Society for Blood and Marrow TransplantationResearch network
- Collaborators
- Amgen, Hoffmann-La Roche
- Study start
- Jan 1995
- Primary completion
- Dec 1999 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone marrow transplantation | Other | Procedure: Bone marrow transplantationPatients received bone marrow transplantation |
| Peripheral blood stem cell transplantation | Other | Procedure: Peripheral blood stem cell transplantationPatients received filgrastim-mobilized peripheral blood stem cell transplantation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone marrow transplantationPatients received bone marrow transplantation | Procedure or surgery | Bone marrow transplantation |
| Peripheral blood stem cell transplantationPatients received filgrastim-mobilized peripheral blood stem cell transplantation | Procedure or surgery | Peripheral blood stem cell transplantation |
Primary outcome
The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.
7 secondary outcomes
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
Overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
- Derived from this study: PubMed 20117965Friedrichs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nobert Schmitz, Prof. study chair
Christian-Albrechts- Universita¨t, Kiel, Germany
H Greinix, Dr principal investigator
Allgemeines Krankenhaus, Vienna, Austria
D Niederwieser, Dr principal investigator
University Hospital Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone marrow transplantation and Peripheral blood stem cell transplantation in people with Acute Leukemia and Chronic Myelogenous Leukemia, run by European Society for Blood and Marrow Transplantation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point of the study was the maximum grade of acute graft versus host (GVH) disease observed in the recipient.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01020175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.