This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in patients with different risk of GVHD. The risk-adapted strategy involves using single-agent cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem cells and mismatched bone marrow.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia
Incidence of acute and chronic GVHD, requiring treatment
Time frame: 365 days
Incidence of primary graft failure
Time frame: 60 days
Non-relapse mortality analysis
Time frame: 365 days
Overall survival analysis
Time frame: 365 days
Event-free survival analysis
Time frame: 365 days
Relapse rate analysis
Time frame: 365 days
Toxicity based NCI CTC grades
Time frame: 100 days
Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence
Time frame: 100 days
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