David Miklos
A Phase II Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft versus Host Disease
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
We hypothesize the addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, and enable a more rapid and effective steroid taper.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Rituximab
Phase:
N/AEligibility
Ages Eligible for Study:
1 years to 75 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Both children and adults with a new diagnosis of chronic GVHD, must include skin involvement, with indication for systemic immunosuppressive treatment to a dose of 1mg/kg prednisone who has undergone any type of donor hematopoietic cell graft or conditioning regimen. See Appendix for NIH Consensus Signs and symptoms Chronic GVHD. The NIH cGVHD Working group recommendation for Diagnosis of chronic GVHD requires a diagnostic sign or at least 1 distinctive manifestation of cGVHD with the diagnosis confirmed by pertinent biopsy or radiology confirmation or Schirmer's test. The guideline for indication to start systemic steroids is as follows:
- 2 or more organs involved (must include skin) with organ score e 2 (see Appendix for organ scoring)
- 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.
Key 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 (i.e. Patient was treated for acute GVHD with prednisone, and developed chronic GVHD before completing taper).
- 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 or lactation
- Inability to comply with the Rituximab treatment regimen.
Additional Study Details
Official Title:
A Phase II Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft versus Host DiseaseAnticipated start date:
8/18/2006Lead Sponsor:
Stanford UniversityCollaborator(s):
- National Institutes of Health (NIH)
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- To determine the efficacy of two 4 week courses of Rituximab as first-line treatment for chronic GVHD. Efficacy endpoint will be defined as the ability to successfully taper prednisone to a dose of 0.25 mg/kg/day by 6 months without clinical relapse.
Secondary Outcomes:
- To have physician documentation of clinical GVHD response using organ staging and scoring scale (see Appendix)
- To evaluate steroid use at one year after enrollment on the trial.
- To monitor patient reported outcomes of GVHD response (see Appendix)
- To monitor infectious complications
- To report freedom from progression (FFP), event free survival (EFS), and overall survival (OS)
- To document treatment failure-defined as initiation of another immunosuppressive agent
Total Number to be Enrolled:
36Total Number to be Enrolled at Stanford:
36More Information
Secondary ID(s):
- 96950
- BMT177
- NCT00350545
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/24/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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