A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT00350545
Status
Completed

Conditions

  • Graft vs Host Disease

Eligibility Criteria

Sex
ALL
Age
1 Year - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
  • Prednisone — DRUG
    1 mg/kg; po per day with taper
  • Cyclosporine A — DRUG
    trough 200-300 or lower; po
  • tacrolimus — DRUG
    trough 5-10 or lower; po

Study Details

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.

Key Dates

Start date
Aug 31, 2006
Status verified
Oct 2017
Primary completion
May 31, 2012
Completion
Oct 31, 2014

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: rituximab + prednisone arm
    Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered.

Primary Outcome Measure

Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

Find similar trials in Stanford, CA

By research site
Stanford University School of Medicine· Stanford, CA

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