Graft Versus Host DiseasePhase 1NCT00373815
Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease
A Phase 1 study testing Everolimus in people with Graft Versus Host Disease, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Graft Versus Host Disease
- What is being tested?
- Everolimus
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Oct 2009
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to inclusion into the study
- Allogeneic HSCT from HLA-identical related or unrelated donors
- Clinically confirmed acute GVHD ≥ grade II
- Age < 70 / > 18 years, male or female
- Karnofsky performance status > 60 %
Who cannot join
- Oral treatment is not feasible
- Severe hepatic impairment Child-Pugh C
- Active cerebral epilepsy
- Renal failure (Creatinine clearance < 50 ml/min)
- Life expectancy < 3 months
- Known hypersensitivity to everolimus, sirolimus or to any of the excipients
Show all 10Show fewer
- Confirmed pregnancy (serum β-HCG)
- Non-effective contraception for both, male and female patients, if the risk of conception exists
- Patients with limited legal capacity
- Patients unwilling and unable to undergo study procedures
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Center, Hematology & Oncology, University of Tuebingen
Tübingen, D-72076
About this study
Official title: A Phase I Dose Escalation Study With Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.
Read the detailed description
The primary objective of the present study is to evaluate the feasibility of treatment with everolimus in combination with CSA/prednisolone in patients with aGVHD after allogeneic HSCT. This evaluation takes into account the following parameters:
- Feasibility of oral application everolimus
- Daily dose needed to reach the targeted plasma level everolimus
- Time to reach the targeted plasma level of everolimusSecondary objectivesThe study will evaluate the toxicity and safety of the treatment with ever-olimus/CSA/prednisolone with regard to
- Incidence and severity of treatment induced toxic events
- Incidence, severity and seriousness of adverse events
- Treatment induced morbidity
- Treatment induced 1-year-mortality Furthermore the study will collect data about
- Efficacy of everolimus/CSA/prednisolone on aGVHD
- Drug interactions between everolimus and CSA
- Conditions
- Graft Versus Host Disease
- Being tested
- Everolimus
- Keywords
- acute GVHD, Immunosuppression
- 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.
EverolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of oral application everolimus
Daily dose needed to reach the targeted plasma level everolimus
Time to reach the targeted plasma level of everolimus
Secondary outcomes (6)
Incidence and severity of treatment induced toxic events
Incidence, severity and seriousness of adverse events
Treatment induced morbidity
Treatment induced 1-year-mortality
Efficacy of everolimus/CSA/prednisolone on aGVHD
Drug interactions between everolimus and CSA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startSep 2006
- Study completionOct 2009
Why it stopped: high incidence of TTP, poor recrual
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 University Hospital TuebingenThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang A Bethge, MD, Principal investigator, Medical Center University of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373815
- Sponsor's protocol ID
- 2006-002577-44
- Status last verified
- May 2014
- First submitted
- 6 Sep 2006
- Last updated
- 29 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study With Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Acute GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00373815
- Acronym / sponsor ID
- 2006-002577-44
- Conditions
- Graft Versus Host Disease
- Keywords
- acute GVHD, Immunosuppression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: high incidence of TTP, poor recrual
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Sep 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 present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.
Detailed description
The primary objective of the present study is to evaluate the feasibility of treatment with everolimus in combination with CSA/prednisolone in patients with aGVHD after allogeneic HSCT. This evaluation takes into account the following parameters:
- Feasibility of oral application everolimus
- Daily dose needed to reach the targeted plasma level everolimus
- Time to reach the targeted plasma level of everolimusSecondary objectivesThe study will evaluate the toxicity and safety of the treatment with ever-olimus/CSA/prednisolone with regard to
- Incidence and severity of treatment induced toxic events
- Incidence, severity and seriousness of adverse events
- Treatment induced morbidity
- Treatment induced 1-year-mortality Furthermore the study will collect data about
- Efficacy of everolimus/CSA/prednisolone on aGVHD
- Drug interactions between everolimus and CSA
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent prior to inclusion into the study
- Allogeneic HSCT from HLA-identical related or unrelated donors
- Clinically confirmed acute GVHD ≥ grade II
- Age < 70 / > 18 years, male or female
- Karnofsky performance status > 60 %
Key exclusion criteria (10 listed)
- Oral treatment is not feasible
- Severe hepatic impairment Child-Pugh C
- Active cerebral epilepsy
- Renal failure (Creatinine clearance < 50 ml/min)
- Life expectancy < 3 months
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 |
|---|---|---|
| Everolimus | Drug | – |
Primary outcome
Feasibility of oral application everolimus
Daily dose needed to reach the targeted plasma level everolimus
Time to reach the targeted plasma level of everolimus
6 secondary outcomes
Incidence and severity of treatment induced toxic events
Incidence, severity and seriousness of adverse events
Treatment induced morbidity
Treatment induced 1-year-mortality
Efficacy of everolimus/CSA/prednisolone on aGVHD
Drug interactions between everolimus and CSA
Results and safety
The study was stopped early (reason given: high incidence of TTP, poor recrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
- Related InfoLink provided by the sponsor.
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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.
Wolfgang A Bethge, MD principal investigator
Medical Center University of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Everolimus in people with Graft Versus Host Disease, run by University Hospital Tuebingen at 1 site in Germany.
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 5 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: stopped early, as of the sponsor's last update on 29 May 2014. 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 Germany. 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 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.
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: high incidence of TTP, poor recrual). 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?
Feasibility of oral application everolimus. The study lists 3 primary outcomes in all. 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 29 May 2014.