N/A
N=37
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
Graft vs Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT00350545 ↗Enrolled (actual)
37
Serious AEs
100.0%
Results posted
Nov 2017
Primary outcome: Primary: Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. — 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rituximab (Drug); Prednisone (Drug); Cyclosporine A (Drug); tacrolimus (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. |
14 | — |
| SECONDARY Number of Participants With Complete and/or Partial GVHD Response |
12; 15 | — |
| SECONDARY Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial |
14 | — |
| SECONDARY Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation |
28; 21 | — |
| SECONDARY Overall Survival |
33; 30 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00350545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.