Acute Graft-versus-Host DiseasePhase 3NCT00282503
Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease
A Phase 3 study testing Methoxsalen+ECP, Methylprednisolone and Ecp in people with Acute Graft-versus-Host Disease, run by Mallinckrodt at 35 sites in 11 countries.
Trial summary
The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft-versus-Host Disease
- What is being tested?
- Methoxsalen+ECP, Methylprednisolone and Ecp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 35 sitesin 11 countries
- Study dates
- Jan 2006to Jun 2007
- 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
- Signed informed consent must be obtained prior to conducting any study procedure.
- Patients must be greater than or equal to 18 years old and weigh greater than or equal to 40 kg (88 lb).
- Patients must have received an allogeneic hematopoietic BMT or PBSCT with myeloablative or reduced-intensity conditioning and have a new onset of acute GvHD, Grades II to III, which includes the skin and developed within 100 days following an allo-HPCT.
- Patients must have received an allogeneic hematopoietic BMT or PBSCT from a related or unrelated donor that is matched at a minimum at the HLA-A, -B, and -DR loci (i.e., at least a 6 out of 6 match). HLA-A and -B match should be determined by serologic testing, and HLA-DR should be matched by molecular methods.
- Patients must be receiving only a calcineurin inhibitor at study entry as part of their acute GvHD prophylactic regimen. Patients may have received additional immunosuppressants for acute GvHD prophylaxis prior to study entry.
- Patients must have a Karnofsky performance greater than or equal to 50.
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- Patients must be able and willing to comply with all study procedures.
- Patients must receive, or must have received, the first corticosteroid dose of approximately 2.0 mg/kg/day but no more than 2.5 mg/kg/day (methylprednisolone equivalent) within 24 hours of the initial diagnosis of Grade II to III acute GvHD. (Up to 2.5 mg/kg/day is allowed for inadvertent dosing fluctuations for reasons other than lack of response.)
- Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (acceptable methods include hormonal contraceptives, intrauterine device, and spermicide and barrier). Abstinence or partner/spouse sterility may also qualify at the Investigator's discretion. If a female patient is of childbearing potential, she must have a negative urine pregnancy test at screening. Male patients must also commit to using adequate contraceptive precautions (condoms). All patients (both males and females of childbearing potential) must commit to using adequate contraceptive precautions throughout their participation in the study and for at least 3 months following their last ECP treatment.
Who cannot join
- Patients who have been diagnosed with chronic GvHD, including de novo chronic GvHD, prior to 100 days following an allo-HPCT.
- Patients who have received donor lymphocyte infusions.
- Patients with uncontrolled life-threatening infections.
- Patients who have a white blood cell (WBC) count < 1.5 x 10^9/L (1,500/mcL).
- Patients who have a platelet count < 20.0 x 10^9/L (20,000/mcL), despite platelet transfusion.
- Patients whose total bilirubin is greater than or equal to 22 mg/dL.
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- Patients who have an International Normalized Ratio (INR) greater than or equal to 2.
- Patients who are enrolled in any concomitant investigation for the treatment of acute GvHD.
- Patients who are unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, hepatic encephalopathy, or hepatorenal syndrome.
- Female patients whose hemoglobin (Hgb) is < 8.5 g/dL or male patients whose Hgb is < 10.0 g/dL at screening, despite packed red blood cell transfusion.
- Patients who have a poor tolerability of venipuncture or a lack of adequate venous access for required treatments and blood sampling.
- Patients who have a known hypersensitivity or allergy to Oxsoralen (methoxsalen).
- Patients who have a known hypersensitivity or allergy to both heparin and citrate products.
- Female patients who are pregnant and/or lactating.
- Patients who have co-existing melanoma, basal cell or squamous cell skin carcinoma, aphakia, photosensitive disease (e.g., porphyria, systemic lupus erythematosus, or albinism), white blood cell count > 25,000 cells/mm3, previous splenectomy, or coagulation disorders.
Trial locations and contacts
35 sites in 11 countries.
35 sites in 11 countries
Germany10 sites
University of Koln
Cologne, 50924
University of Dresden
Dresden, D-01307
Klinikum der Universitat Erlangen-Nurnberg
Erlangen, 91054
Universitats Hautklinik
Essen, 45122
Universitatskrankenhaus Hamburg-Eppendorf
Hamburg, 20246
Universitatsklinikum Leipzig
Leipzig, 04103
Ludwig-Maximillians-Universitat Munchen
München, 81377
Universitat Regensburg
Regensburg, D-93042
University of Rostock
Rostock, 18057
Stammzelltransplantationzentrum der Universitat Wurzbrug
Würzburg, 97080
United States5 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 58109
University of Florida
Gainesville, Florida, 32610
Weill Medical College of Cornell University
New York, New York, 10021
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Leukemia and Bone Marrow Transplant Center - Avera Cancer Institute
Sioux Falls, South Dakota, 57117
Canada4 sites
Maisonneuve-Rosemont Hopital
Montreal, H1T 2M4
Royal Victoria Hospital
Montreal, H3A 1A1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Vancouver General Hopsital
Vancouver, British Columbia, V5Z 4E3
Australia3 sites
Royal Brisbane Women's Hospital
Brisbane, 4029
Saint Vincent's Hospital
Darlinghurst, NSW 2010
Westmead Hospital
Westmead, NSW 2145
Belgium3 sites
Universite Catholique De Louvain
Brussels, 1200
University Hospital Gasthuisberg
Leuven, B30000
Centre Hopitalier Universitaire Sart Tilman Liege
Liège, 4000
United Kingdom3 sites
Hammersmith Hospital
London, W12 0NN
Royal Victoria Infirmary
Newcastle, NE1 4LP
Rotheram General Hospital
Rotheram Yorkshire, S60
France2 sites
Centre Hospitalier Universitaire Hospital Bordeaux
Bordeaux
St. Louis Hospital
Paris, 75010
Italy2 sites
San Martino Hospital
Genova, 16132
Universita di Siena Policlinico Le Scotte
Siena, Sienna, i-50139
About this study
Official title: A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease
The purpose of this study is to compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.
- Conditions
- Acute Graft-versus-Host Disease
- Being tested
- Methoxsalen+ECP, Methylprednisolone, Ecp
- Keywords
- aGvHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxsalen+ECP, MethylprednisoloneDrug
Also called Uvadex+ ECP
Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:
- Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
- Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be > 4 days between the ECP treatments within a week.)
Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions:
Daily Dose (mg/kg)
1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10
EcpProcedure or surgery
ECP or Extra Corporeal Phototherapy will be used with UVADex
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone equivalent. | Active comparator | 2mg/kg daily will be administered initially and may be tapered according to a tapering schedule provided in the protocol. Receives: Drug: Methoxsalen+ECP, Methylprednisolone |
| Uvadex+ECP | Experimental | Those patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen:
* Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period),
* Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days Receives: Drug: Methoxsalen+ECP, Methylprednisolone; Procedure: Ecp |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.
The primary efficacy analysis will be performed on the primary endpoint. The primary efficacy variable in this study is complete resolution of acute GvHD, defined as less than Grade I acute GvHD, according to the Glucksberg-Seattle criteria.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2007
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-Host DiseaseStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282503
- Sponsor's protocol ID
- Acute GvHD-1
- Status last verified
- Aug 2017
- First submitted
- 24 Jan 2006
- Last updated
- 16 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel-Group, Multicenter Study of Extracorporeal Photoimmune Therapy With THERAKOS* UVADEX* for the Treatment of Patients With Newly Diagnosed Acute Graft Versus-Host Disease
- ClinicalTrials.gov ID
- NCT00282503
- Acronym / sponsor ID
- Acute GvHD-1
- Conditions
- Acute Graft-versus-Host Disease
- Keywords
- aGvHD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- First posted
- 26 Jan 2006 (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 safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in the treatment of patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone equivalent. | Active comparator | Drug: Methoxsalen+ECP, Methylprednisolone2mg/kg daily will be administered initially and may be tapered according to a tapering schedule provided in the protocol. |
| Uvadex+ECP | Experimental | Drug: Methoxsalen+ECP, Methylprednisolone, Procedure: EcpThose patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen: * Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period), * Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent must be obtained prior to conducting any study procedure.
- Patients must be greater than or equal to 18 years old and weigh greater than or equal to 40 kg (88 lb).
- Patients must have received an allogeneic hematopoietic BMT or PBSCT with myeloablative or reduced-intensity conditioning and have a new onset of acute GvHD, Grades II to III, which includes the skin and developed within 100 days following an allo-HPCT.
- Patients must have received an allogeneic hematopoietic BMT or PBSCT from a related or unrelated donor that is matched at a minimum at the HLA-A, -B, and -DR loci (i.e., at least a 6 out of 6 match). HLA-A and -B match should be determined by serologic testing, and HLA-DR should be matched by molecular methods.
- Patients must be receiving only a calcineurin inhibitor at study entry as part of their acute GvHD prophylactic regimen. Patients may have received additional immunosuppressants for acute GvHD prophylaxis prior to study entry.
Key exclusion criteria (15 listed)
- Patients who have been diagnosed with chronic GvHD, including de novo chronic GvHD, prior to 100 days following an allo-HPCT.
- Patients who have received donor lymphocyte infusions.
- Patients with uncontrolled life-threatening infections.
- Patients who have a white blood cell (WBC) count < 1.5 x 10^9/L (1,500/mcL).
- Patients who have a platelet count < 20.0 x 10^9/L (20,000/mcL), despite platelet transfusion.
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 |
|---|---|---|
| Methoxsalen+ECP, MethylprednisoloneAlso: Uvadex+ ECPThose patients randomized to the ECP Treatment arm will receive ECP treatments by the following regimen: * Weeks 1 through Week 3 - 3 times within each week. (Treatments do not have to be performed on consecutive days but should be completed within the 7-day period), * Weeks 4 through 12 - 2 times each week. (It is preferable that patients receive ECP treatments on consecutive days within a week, but there should never be > 4 days between the ECP treatments within a week.) Methylprednisolone will be started at 2mg/kg daily dose and may be tapered by reducing dose each week at the following reductions: Daily Dose (mg/kg) 1 1.5 2 1.0 3 0.70 4 0.50 5 0.40 6 0.30 7 0.20 8 0.10 | Drug | Uvadex+ECP, methylprednisolone equivalent. |
| EcpECP or Extra Corporeal Phototherapy will be used with UVADex | Procedure or surgery | Uvadex+ECP |
Primary outcome
To compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT.
Time frame: 8 weeks
The primary efficacy analysis will be performed on the primary endpoint. The primary efficacy variable in this study is complete resolution of acute GvHD, defined as less than Grade I acute GvHD, according to the Glucksberg-Seattle criteria.
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methoxsalen+ECP, Methylprednisolone and Ecp in people with Acute Graft-versus-Host Disease, run by Mallinckrodt at 35 sites in 11 countries.
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 9 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany, United States, Canada, Australia, Belgium and 6 more countries. 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 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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 compare the safety and efficacy of ECP treatment combined with high dose corticosteroids versus high dose corticosteroids alone, in patients with newly diagnosed acute GvHD (Grades II to III) that developed within 100 days following an allo HPCT. (time frame: 8 weeks). 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 16 Aug 2017.