Clinical trial NCT00350545: A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
Official title: A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft vs Host Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 37
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children and adults with a new diagnosis of chronic GVHD- that requires systemic immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone any type of donor hematopoietic cell graft or conditioning regimen.
* Stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors, mycophenolate mofetil) for 2 weeks prior to enrollment. In addition, these other immunosuppressive medications should not be dose increased.
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
* All subjects must provide written informed consent.

Exclusion Criteria:

* Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody.
* Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg is allowed.
* Active, uncontrolled infection- CMV reactivation is excluded (i.e. pneumonitis, colitis). Peripheral blood CMV reactivation is allowed as long as it is not associated with CMV disease and is responding to therapy.
* Known Hepatitis B surface Ag positive
* Active malignant disease relapse.
* Pregnancy
* Lactating
* Inability to comply with the Rituximab treatment regimen.

Primary outcomes:
measure: Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Complete and/or Partial GVHD Response
timeFrame: 6 months
measure: Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial
timeFrame: 1 year
measure: Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation
timeFrame: 6 and 12 Months
measure: Overall Survival
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: David Miklos
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Sally Arai
role: PRINCIPAL_INVESTIGATOR
References: