Myelodysplastic Syndrome Clinical Trial
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.
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
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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