Graft vs Host DiseasePhase 1/2NCT00136396
Rituximab Therapy for Steroid-Refractory Chronic Graft Versus Host Disease
A Phase 1/2 study testing Rituximab in people with Graft vs Host Disease, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- Rituximab
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to Nov 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of matched related, matched unrelated, or mismatched stem cell transplantation
- At least 180 days since allogeneic stem cell transplantation procedure
- Patients must have steroid-refractory chronic GVHD, defined as having persistent signs and symptoms despite the use of prednisone
- Stable dose of corticosteroids for 4 weeks prior to enrollment
- Adequate bone marrow function: absolute neutrophil count (ANC) > 500/mm; platelets > 20,000 ul
- Adequate renal function: creatinine < 3.0 mg/dl
- Adequate hepatic function: bilirubin < 3.0 mg/dl; AST < 90 IU
Who cannot join
- Prednisone requirement greater than 2 mg/kg/day or equivalent
- Known life-threatening sensitivity to rituximab or other anti-B cell antibody.
- Prior exposure to any new immunosuppressive medication in the preceding 4 weeks prior to enrollment.
- Active, uncontrolled infection
- Evidence of natural exposure to hepatitis B or C.
- Active malignant disease relapse
Show all 10Show fewer
- Donor lymphocyte infusion within the preceding 100 days.
- Life expectancy of less than 3 months.
- Pregnancy or lactation
- Evidence of HIV seropositivity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease
The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).
Read the detailed description
Patients will receive rituximab intravenously one time per week for four consecutive weeks. Once therapy is completed, the patient will have weekly visits with their physician for four more weeks, at which they will complete a simple questionnaire designed to evaluate the severity of chronic graft versus host disease.
At the end of the eighth week on the study (4 weeks of study treatment and 4 weeks of observation), patients will be evaluated to determine whether their chronic graft versus host disease (GVHD) has resolved.
If chronic graft versus host disease has resolved entirely, the patient will be monitored for the remainder of the year.
If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD, they may receive a second four week study treatment.
If the patients' chronic GVHD reappears after receiving either one or two courses of rituximab, a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose.
Blood tests will be performed at the beginning of the study, after 8 weeks on the study, after 16 weeks on the study and at the end of 1 year.
- Conditions
- Graft vs Host Disease
- Being tested
- Rituximab
- Keywords
- Steroid-refractory Chronic Graft vs. Host Disease, Chronic Graft vs. Host Disease, GVHD, steroid-refractory, rituximab
- 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
Given once weekly for 4 weeks followed by a 4 week observation therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD
Measured: 2 years
Secondary outcomes (1)
To determine the effects of rituximab therapy on quality of life of patients with steroid-refractory GVHD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startJan 2004
- Primary completionNov 2006
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft vs Host DiseaseStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Corey S. Cutler, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136396
- Sponsor's protocol ID
- 03-120
- Status last verified
- Jun 2013
- First submitted
- 26 Aug 2005
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cutler C, Miklos D, Kim HT, Treister N, Woo SB, Bienfang D, Klickstein LB, Levin J, Miller K, Reynolds C, Macdonell R, Pasek M, Lee SJ, Ho V, Soiffer R, Antin JH, Ritz J, Alyea E. Rituximab for steroid-refractory chronic graft-versus-host disease. Blood. 2006 Jul 15;108(2):756-62. doi: 10.1182/blood-2006-01-0233. Epub 2006 Mar 21.
PubMed 16551963
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase I/II Trial of Rituximab Therapy for Steroid-Refractory Chronic Graft vs. Host Disease
- ClinicalTrials.gov ID
- NCT00136396
- Acronym / sponsor ID
- 03-120
- Conditions
- Graft vs Host Disease
- Keywords
- Steroid-refractory Chronic Graft vs. Host Disease, Chronic Graft vs. Host Disease, GVHD, steroid-refractory, rituximab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jan 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if rituximab is a safe and effective therapy for steroid-refractory chronic graft versus host disease (GVHD).
Detailed description
Patients will receive rituximab intravenously one time per week for four consecutive weeks. Once therapy is completed, the patient will have weekly visits with their physician for four more weeks, at which they will complete a simple questionnaire designed to evaluate the severity of chronic graft versus host disease.
At the end of the eighth week on the study (4 weeks of study treatment and 4 weeks of observation), patients will be evaluated to determine whether their chronic graft versus host disease (GVHD) has resolved.
If chronic graft versus host disease has resolved entirely, the patient will be monitored for the remainder of the year.
If after the initial eight weeks on the study the patient still has symptoms or signs of GVHD, they may receive a second four week study treatment.
If the patients' chronic GVHD reappears after receiving either one or two courses of rituximab, a third and final four week course of medication can be given provided it has been at least eight weeks since the last dose.
Blood tests will be performed at the beginning of the study, after 8 weeks on the study, after 16 weeks on the study and at the end of 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Recipients of matched related, matched unrelated, or mismatched stem cell transplantation
- At least 180 days since allogeneic stem cell transplantation procedure
- Patients must have steroid-refractory chronic GVHD, defined as having persistent signs and symptoms despite the use of prednisone
- Stable dose of corticosteroids for 4 weeks prior to enrollment
- Adequate bone marrow function: absolute neutrophil count (ANC) > 500/mm; platelets > 20,000 ul
Key exclusion criteria (10 listed)
- Prednisone requirement greater than 2 mg/kg/day or equivalent
- Known life-threatening sensitivity to rituximab or other anti-B cell antibody.
- Prior exposure to any new immunosuppressive medication in the preceding 4 weeks prior to enrollment.
- Active, uncontrolled infection
- Evidence of natural exposure to hepatitis B or C.
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 |
|---|---|---|
| RituximabGiven once weekly for 4 weeks followed by a 4 week observation therapy. | Drug | – |
Primary outcome
To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD
Time frame: 2 years
1 secondary outcome
To determine the effects of rituximab therapy on quality of life of patients with steroid-refractory GVHD
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Derived from this study: PubMed 16551963Cutler C, Miklos D, Kim HT, Treister N, Woo SB, Bienfang D, Klickstein LB, Levin J, Miller K, Reynolds C, Macdonell R, Pasek M, Lee SJ, Ho V, Soiffer R, Antin JH, Ritz J, Alyea E. Rituximab for steroid-refractory chronic graft-versus-host disease. Blood. 2006 Jul 15;108(2):756-62. doi: 10.1182/blood-2006-01-0233. Epub 2006 Mar 21.
Related trials for Graft vs Host Disease
Active, not recruitingPhase 2
De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis
Graft-versus-host Disease
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
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.
Corey S. Cutler, MD, MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rituximab in people with Graft vs Host Disease, run by Dana-Farber Cancer Institute at 2 sites 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 7 inclusion and 10 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 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the safety and efficacy of up to three four week courses of rituximab in steroid-refractory chronic GVHD (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00136396, which also lists 1 linked publication.
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 12 Jun 2013; AzTrials last refreshed its copy on 6 Nov 2026.