Chronic Graft-versus-host DiseasePhase 2NCT01226420
Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
A Phase 2 study testing Alefacept in people with Chronic Graft-versus-host Disease, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like chronic GVHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft-versus-host Disease
- What is being tested?
- Alefacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2010to Aug 2012
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosed with cGVHD according to NIH criteria
- Active cGVHD despite treatment with corticosteroids AND one additional immunosuppressive agent for at least 4 weeks, within 52 weeks of enrollment.
- Subject is a recipient of related or unrelated BMT or PBSCT
- Subject underwent transplantation at least 6 months prior to enrollment
- Subject is on stable immunosuppressive regimen for 2 weeks prior to enrollment. Adjustment of immunosuppressive medications to maintain a therapeutic level is permitted.
- Female of child bearing potential must have a negative pregnancy test prior to first dose of alefacept and must agree to practice effective contraception during the study. Men must also agree to use adequate contraception prior to study entry and for the duration of the study.
- Meets medication restriction requirements and agrees to follow medications restrictions during study.
Who cannot join
- Received donor lymphocyte infusions in the preceding 100 days
- Currently undergoing ECP
- Subject is recipient of related or unrelated UCB
- Subject has bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia or cryptogenic organizing pneumonia as the sole manifestation of cGVHD
- Uncontrolled intercurrent active infection.
- Absolute neutrophil count < 1000/L
Show all 15Show fewer
- AST, ALT or total bilirubin > 2x institutional upper limit of normal unless this is a manifestation of GVHD
- Recurrent or progressive malignancy at any time after HCT, as applicable for the individual malignancy
- Subject was in any clinical study within the last 30 days
- Receipt of 5 or more prior agents to treat cGVHD
- Known hypersensitivity to alefacept or any components of the study medication
- Known to be positive for human immunodeficiency virus (HIV) antibodies
- Currently enrolled in any other study for chronic GVHD treatment and receiving treatment under the study or previous participation in this study.
- Pregnant or nursing
- Concurrent illness which, in the opinion of the Investigator, may interfere with treatment or evaluation of safety
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Fred Hutch Cancer Research Center
Seattle, Washington, 98109-1024
About this study
Official title: A Phase II, Open-Label, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can develop after allogeneic stem cell transplantation. It occurs when the donor immune cells (the "graft") attack and damage organs and tissue (the "host"). It is thought that T cells, a subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this research study we are looking to see how well Alefacept works in treating chronic GVHD that has not resolved after therapy with corticosteroids.
Read the detailed description
- During the first week of treatment, participants will receive 2 doses of Alefacept intravenously (Day 1 and Day 4). During weeks 2-12, Alefacept will be given subcutaneously once weekly.
- On weeks 1, 2 and every other week through Week 12 of study treatment, participants will have a physical exam, blood tests, and be asked general health and specific questions about any problems they may be having.
- Every other week, participants will be asked to complete a questionnaire about their physical symptoms, activity level and emotional well being.
- Conditions
- Chronic Graft-versus-host Disease
- Being tested
- Alefacept
- Keywords
- GVHD, Alefacept, Amevive
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlefaceptDrug
Also called Amevive
Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12
| Study group | Role | What they receive |
|---|---|---|
| Alefacept | Experimental | Alefacept iv Receives: Drug: Alefacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.
Measured: 2 years
Secondary outcomes (1)
Safety of Alefacept Infusions in Patients With Chronic GVHD.
Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.
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 posted22 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Discontinuation of drug supply from Astellas.
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 Chronic Graft-versus-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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Astellas Pharma Inc
- Responsible party
- Principal investigator, Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Corey Cutler, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226420
- Sponsor's protocol ID
- 10-230
- Status last verified
- Aug 2013
- First submitted
- 21 Oct 2010
- Last updated
- 13 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
- ClinicalTrials.gov ID
- NCT01226420
- Acronym / sponsor ID
- 10-230
- Conditions
- Chronic Graft-versus-host Disease
- Keywords
- GVHD, Alefacept, Amevive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of drug supply from Astellas.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Astellas Pharma Inc
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Posted 13 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can develop after allogeneic stem cell transplantation. It occurs when the donor immune cells (the "graft") attack and damage organs and tissue (the "host"). It is thought that T cells, a subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this research study we are looking to see how well Alefacept works in treating chronic GVHD that has not resolved after therapy with corticosteroids.
Detailed description
- During the first week of treatment, participants will receive 2 doses of Alefacept intravenously (Day 1 and Day 4). During weeks 2-12, Alefacept will be given subcutaneously once weekly.
- On weeks 1, 2 and every other week through Week 12 of study treatment, participants will have a physical exam, blood tests, and be asked general health and specific questions about any problems they may be having.
- Every other week, participants will be asked to complete a questionnaire about their physical symptoms, activity level and emotional well being.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alefacept | Experimental | Drug: AlefaceptAlefacept iv |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Diagnosed with cGVHD according to NIH criteria
- Active cGVHD despite treatment with corticosteroids AND one additional immunosuppressive agent for at least 4 weeks, within 52 weeks of enrollment.
- Subject is a recipient of related or unrelated BMT or PBSCT
- Subject underwent transplantation at least 6 months prior to enrollment
Key exclusion criteria (15 listed)
- Received donor lymphocyte infusions in the preceding 100 days
- Currently undergoing ECP
- Subject is recipient of related or unrelated UCB
- Subject has bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia or cryptogenic organizing pneumonia as the sole manifestation of cGVHD
- Uncontrolled intercurrent active infection.
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 |
|---|---|---|
| AlefaceptAlso: AmeviveGiven intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12 | Drug | Alefacept |
Primary outcome
Efficacy
Time frame: 2 years
Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.
1 secondary outcome
Safety of Alefacept Infusions in Patients With Chronic GVHD.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Cutler, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alefacept in people with Chronic Graft-versus-host Disease, run by Dana-Farber Cancer Institute at 3 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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 13 Aug 2013). 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?
Efficacy (time frame: 2 years). 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 13 Aug 2013.