Graft vs Host DiseaseNCT00350545
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
A study testing Rituximab, Prednisone and Cyclosporine A in people with Graft vs Host Disease, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- Rituximab, Prednisone and Cyclosporine A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Graft vs Host Disease
- Being tested
- Rituximab, Prednisone, Cyclosporine A, tacrolimus
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Rituxan
375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
PrednisoneDrug
Also called Deltasone, Liquid Pred, Meticorten, Orasone
1 mg/kg; po per day with taper
Cyclosporine ADrug
Also called cyclosporine, Ciclosporin
trough 200-300 or lower; po
tacrolimusDrug
Also called FK-506, Fujimycin
trough 5-10 or lower; po
| Study group | Role | What they receive |
|---|---|---|
| rituximab + prednisone arm | Experimental | 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. Receives: Drug: Rituximab; Drug: Prednisone; Drug: Cyclosporine A; Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
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
Measured: 1 year
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.
Measured: 6 and 12 Months
Overall Survival
Overall survival at 6 and 12 months
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startAug 2006
- Primary completionMay 2012
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Arai, Stanford University
- Investigators
- David Miklos, Principal investigator, Stanford UniversitySally Arai, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350545
- Sponsor's protocol ID
- IRB-04948
- Other IDs
- 96950, BMT177, NCI-2011-00450
- Status last verified
- Oct 2017
- First submitted
- 5 Jul 2006
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD will be available in the publication which is forthcoming.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT00350545
- Acronym / sponsor ID
- IRB-04948
- Conditions
- Graft vs Host Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab + prednisone arm | Experimental | Drug: Rituximab, Drug: Prednisone, Drug: Cyclosporine A, Drug: tacrolimusRituximab 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. |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: Rituxan375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9 | Drug | rituximab + prednisone arm |
| PrednisoneAlso: Deltasone, Liquid Pred, Meticorten, Orasone1 mg/kg; po per day with taper | Drug | rituximab + prednisone arm |
| Cyclosporine AAlso: cyclosporine, Ciclosporintrough 200-300 or lower; po | Drug | rituximab + prednisone arm |
| tacrolimusAlso: FK-506, Fujimycintrough 5-10 or lower; po | Drug | rituximab + prednisone arm |
Primary outcome
Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose.
Time frame: 6 months
Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse.
4 secondary outcomes
Number of Participants With Complete and/or Partial GVHD Response
Time frame: 6 months
Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial
Time frame: 1 year
Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation
Time frame: 6 and 12 Months
Overall Survival
Time frame: 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD will be available in the publication which is forthcoming.
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Graft vs Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Miklos principal investigator
Stanford University
Sally Arai principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab, Prednisone and Cyclosporine A in people with Graft vs Host Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.