Graft Versus Host DiseasePhase 3NCT00053976
Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease
A Phase 3 study testing Daclizumab and methylprednisolone in people with Graft Versus Host Disease, run by Dana-Farber Cancer Institute at 8 sites in United States.
Trial summary
The purpose of this study is to compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Daclizumab and methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 8 sitesUnited States
- Study dates
- Jan 2001to Nov 2004
- Phase
- Phase 3
- 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
- Allogeneic Transplantation
- Acute GVHD requiring therapy (skin stage 2 or overall grade II-IV)
- Signed, informed consent
Who cannot join
- Mental or emotional contraindications as determined by patient's physician
- Steroids given prophylactically or therapeutically at a dose > 1 mg/kg/d methylprednisolone (including prevention of acute GVHD or treatment for diffuse alveolar hemorrhage and severe obstructive mucositis within 7 days prior to starting acute GVHD therapy. Steroids administered as amphotericin premedication are allowed if below 1 mg/kg/day.
- Acute GVHD diagnosed solely by virtue of upper GI GVHD
- Hypersensitivity to Daclizumab or prior therapy with Daclizumab
- GVHD from donor lymphocyte infusion
- Other investigational therapeutics within 30 days of enrollment
- Pregnancy or of fertile, failure to agree to use contraception
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114-2698
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Baylor University Medical Center
Dallas, Texas, 75246
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
Official title: Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo
The purpose of this study is to compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. This research is being done because the investigators do not know whether addition of this new medication to standard corticosteroid therapy improves response rates. Since Zenapax binds to a type of cell which is thought to cause GVHD and possibly inactivates them, investigators have reason to believe that addition of Zenapax night result in better control of GVHD This study will determine whether the addition of another medication, Zenapax, will be more effective than steroids alone in suppressing GVHD and improving symptoms of GVHD.
Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient with kidney transplant to help prevent graft rejection. This medication has been used in bone marrow transplant patients to treat GVHD.
Read the detailed description
GVHD occurs when the donor's immune system recognizes a patient's body as foreign and reacts against it. GVHD may result in skin rashes and blistering, liver inflammation and gastrointestinal problems including nausea, vomiting, diarrhea and bleeding. Mild GVHD may be treated with topical medications applied to the skin. More severe GVHD requires medications given intravenously (by vein) or taken by mouth. Steroids are usually given first to treat GVHD but only 40% of people respond to this alone.
OBJECTIVES:
- Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab.
- Compare differences in total methylprednisolone dose and complications in patients treated with these regimens.
- Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens.
- Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekly as indicated until day 100.
- Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.
Patients are followed at 1 year and then annually thereafter.
- Conditions
- Graft Versus Host Disease
- Being tested
- Daclizumab, methylprednisolone, Placebo
- Keywords
- graft versus host disease
- 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.
DaclizumabBiological
Also called Zenapax
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Daclizumab | Experimental | Patients are randomized to 1 of 2 treatment arms.
Arm I:
* Patients receive methylprednisolone or equivalent corticosteroid IV or orally
* Daclizumab IV on days 0, 3, 7, 14, and then weekly as indicated until day 100.
Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.
Patients are followed at 1 year and then annually thereafter. Receives: Biological: Daclizumab; Drug: methylprednisolone |
| Placebo | Placebo comparator | Patients are randomized to 1 of 2 treatment arms.
* Patients receive methylprednisolone or equivalent corticosteroid as in Daclizumab arm
* Placebo IV on days 0, 3, 7, 14, and then weekly as indicated until day 100. Receives: Drug: methylprednisolone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decrease of acute GVHD grade
Measured: Day 42
Secondary outcomes (8)
100 Day Mortality
Measured: 100 Day
Complete Response of GVHD
Measured: 100 Days
Total Days of Antibiotic or Antifungal
Measured: 100 Days
Number of Hospitalized Days
Measured: 100 Days
Total Steroid Dose
Measured: 100 Days
Number of Participants with Steroid related Complication
Measured: 1 Year
Overall Survival
Measured: 100 Days
Relapse Rate
Measured: 1 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startJan 2001
- Primary completionNov 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Vincent T. Ho, MD, Dana-Farber Cancer Institute
- Investigators
- Stephanie J. Lee, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053976
- Sponsor's protocol ID
- 99-279
- Other IDs
- P30CA016056, P30CA006516, RPCI-DS-0218, ROCHE-RPCI-DS-0218
- Status last verified
- Jan 2017
- First submitted
- 5 Feb 2003
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo
- ClinicalTrials.gov ID
- NCT00053976
- Acronym / sponsor ID
- 99-279
- Conditions
- Graft Versus Host Disease
- Keywords
- graft versus host disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2001
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 6 Feb 2003 (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 compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. This research is being done because the investigators do not know whether addition of this new medication to standard corticosteroid therapy improves response rates. Since Zenapax binds to a type of cell which is thought to cause GVHD and possibly inactivates them, investigators have reason to believe that addition of Zenapax night result in better control of GVHD This study will determine whether the addition of another medication, Zenapax, will be more effective than steroids alone in suppressing GVHD and improving symptoms of GVHD.
Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient with kidney transplant to help prevent graft rejection. This medication has been used in bone marrow transplant patients to treat GVHD.
Detailed description
GVHD occurs when the donor's immune system recognizes a patient's body as foreign and reacts against it. GVHD may result in skin rashes and blistering, liver inflammation and gastrointestinal problems including nausea, vomiting, diarrhea and bleeding. Mild GVHD may be treated with topical medications applied to the skin. More severe GVHD requires medications given intravenously (by vein) or taken by mouth. Steroids are usually given first to treat GVHD but only 40% of people respond to this alone.
OBJECTIVES:
- Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab.
- Compare differences in total methylprednisolone dose and complications in patients treated with these regimens.
- Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens.
- Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekly as indicated until day 100.
- Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo.
Patients are followed at 1 year and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daclizumab | Experimental | Biological: Daclizumab, Drug: methylprednisolonePatients are randomized to 1 of 2 treatment arms. Arm I: * Patients receive methylprednisolone or equivalent corticosteroid IV or orally * Daclizumab IV on days 0, 3, 7, 14, and then weekly as indicated until day 100. Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I and placebo. Patients are followed at 1 year and then annually thereafter. |
| Placebo | Placebo comparator | Drug: methylprednisolone, Drug: PlaceboPatients are randomized to 1 of 2 treatment arms. * Patients receive methylprednisolone or equivalent corticosteroid as in Daclizumab arm * Placebo IV on days 0, 3, 7, 14, and then weekly as indicated until day 100. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Allogeneic Transplantation
- Acute GVHD requiring therapy (skin stage 2 or overall grade II-IV)
- Signed, informed consent
Key exclusion criteria (7 listed)
- Mental or emotional contraindications as determined by patient's physician
- Steroids given prophylactically or therapeutically at a dose > 1 mg/kg/d methylprednisolone (including prevention of acute GVHD or treatment for diffuse alveolar hemorrhage and severe obstructive mucositis within 7 days prior to starting acute GVHD therapy. Steroids administered as amphotericin premedication are allowed if below 1 mg/kg/day.
- Acute GVHD diagnosed solely by virtue of upper GI GVHD
- Hypersensitivity to Daclizumab or prior therapy with Daclizumab
- GVHD from donor lymphocyte infusion
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 |
|---|---|---|
| DaclizumabAlso: Zenapax | Biological | Daclizumab |
| methylprednisolone | Drug | Daclizumab, Placebo |
| Placebo | Drug | Placebo |
Primary outcome
Rate of decrease of acute GVHD grade
Time frame: Day 42
8 secondary outcomes
100 Day Mortality
Time frame: 100 Day
Complete Response of GVHD
Time frame: 100 Days
Total Days of Antibiotic or Antifungal
Time frame: 100 Days
Number of Hospitalized Days
Time frame: 100 Days
Total Steroid Dose
Time frame: 100 Days
Number of Participants with Steroid related Complication
Time frame: 1 Year
Overall Survival
Time frame: 100 Days
Relapse Rate
Time frame: 1 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 23 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Graft Versus 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.
Stephanie J. Lee, MD study chair
Dana-Farber Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daclizumab and methylprednisolone in people with Graft Versus Host Disease, run by Dana-Farber Cancer Institute at 8 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 3 inclusion and 7 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rate of decrease of acute GVHD grade (time frame: Day 42). 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 23 Jan 2017.