Isolated prolonged thrombocytopenia (PT) is a common complication after allogeneic stem cell transplantation with significant poor prognosis. No standard treatment is available. The current study assigned PT randomly to 2 arms: intervention arm with N-acetyl-L-cysteine (NAC) and control arm with supportive therapy.This is a prospective randomized controlled study.
1. patients diagnosed with PT at day 60 post transplant will be randomized assigned to intervention arm (NAC) or controlled arm (supportive therapy: prophylactic platelet transfusion was given when platelet count \<20000/ul.) 2. Response will be evaluated at day 90. Response was defined as platelet recovery to \>= 20000/ul for 7 consecutive days without transfusion support during the enrollment period. All the other patients not achieved above criteria was defined as no response. 3. For those without response in both arms, patients will received NAC plus recombinant human thrombopoietin (rhTPO) for an additional 30 days. rhTPO was given at 300IU/kg/d for 28 consecutive days or platelet \> 50000/ul independent of platelet transfusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
NAC treatment for PT: 400mg p.o tid from day 60 to 90 post transplant
prophylactic platelet transfusion was given when platelet count \<20000/ul
Peking University People's Hospital
Beijing, Beijing Municipality, China
response rate
rate of response after 30 days of treatment
Time frame: 30 days after the start of enrollement
overall survival
survival proportion at the last followup after transplantation
Time frame: the day of last follow-up
non-relapse mortality
non-relapse mortality at the last followup after transplantation
Time frame: the day of last follow-up
grade 2-4 acute graft versus host disease
grade 2-4 aGVHD at day 100 after transplant
Time frame: day 100 after transplant
chronic graft versus host disease
chronic graft versus host disease at the day of last follow-up
Time frame: the day of last follow-up
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