The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.
To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or GVHD relapse/ recurrence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
1 mg/kg; po per day with taper
trough 200-300 or lower; po
Stanford University School of Medicine
Stanford, California, United States
Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.
Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse.
Time frame: 6 months
Number of Participants With Complete and/or Partial GVHD Response
To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began
Time frame: 6 months
Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial
Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began
Time frame: 1 year
Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation
Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment.
Time frame: 6 and 12 Months
Overall Survival
Overall survival at 6 and 12 months
Time frame: 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
trough 5-10 or lower; po