Clinical trial · Interventional
Peripheral Blood (PB) Versus Bone Marrow (BM) in Allogeneic Stem Cell 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone marrow transplantation | Procedure | — | UNRESOLVED |
| Peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Bone marrow transplantation
- description
- Patients received bone marrow transplantation
- interventionNames
- Procedure: Bone marrow transplantation
- type
- OTHER
- label
- Peripheral blood stem cell transplantation
- description
- Patients received filgrastim-mobilized peripheral blood stem cell transplantation
- interventionNames
- Procedure: Peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFriedrichs 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 20117965