NCT01020175

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: European Society for Blood and Marrow Transplantation · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Acute Leukemia
• Chronic Myelogenous Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
PROCEDURE	Bone marrow transplantation	Patients received bone marrow transplantation
PROCEDURE	Peripheral blood stem cell transplantation	Patients received filgrastim-mobilized peripheral blood stem cell transplantation

Timeline

• Start date: 1995-01-01
• Primary completion: 1999-12-01
• Completion: 2002-12-01
• First posted: 2009-11-25
• Last updated: 2009-11-25

Locations

1 site across 1 country: Germany