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

Graft vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350545
• Other study ID #: IRB-04948
• Secondary ID: 96950BMT177NCI-2
• Status: Completed
• Phase: N/A
• First received: July 5, 2006
• Last updated: October 19, 2017
• Start date: August 2006
• Est. completion date: October 2014

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease

Intervention

Drug:
• Rituximab
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
1 mg/kg; po per day with taper
• Cyclosporine A
trough 200-300 or lower; po
• tacrolimus
trough 5-10 or lower; po

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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	6 months
Secondary	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	1 year
Secondary	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.	6 and 12 Months
Secondary	Overall Survival	Overall survival at 6 and 12 months	6 and 12 months