Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)Phase 2NCT01509560
PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood
A Phase 2 study testing Everolimus in people with Condition After Allogenic Peripheral Stem Cell Transplantation (SCT), run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 1 site in Germany.
Trial summary
In this prospective study is to examine whether the use of everolimus in patients after allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is appropriate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2011to 30 Apr 2016
- Phase
- Phase 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
- Patients after allogeneic stem cell transplantation aged ≥ 18 years
- Prophylaxes of GvHD with calcineurin inhibitors (Ciclosporine A, Tacrolimus) and MTX or MMF (previous therapy of acute GvHD with additional prednisone is permitted)
- Increased risk of chronic GvHD, defined by
- Male with female donor
- HLA mismatch class I- or II towards GvHD
- Persistant active acute GvHD on day +50 after stem cell transplantation despite of high-dose steroids and cyclosporine
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- Reduction of baseline FEV1 or DLCO (examined 0 - 50 days before transplantation) of ≥ 25%
- New occurrence of acute GvHD between day +50 and +100 after stem cell transplantation
- Informed concent
Who cannot join
- Use (prophylactic or therapeutic) of mTor inhibitors after SCT
- Overlap of acute and chronic GvHD
- Total cholesterol ≥ 3-fold of upper limit (UL) or triglycerides ≥ 3-fold UL
- GOT, GPT, Bilirubin ≥ 3-fold UL (if not related to GvHD)
- Creatinine ≥ 3-fold UL
- Confirmed active hepatitis B or C
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- All circumstances where impaired wound healing might be a risk factor, esp. surgical interventions in the last weeks, ulcers of skin or mucosa
- Known intolerance to Everolimus, Sirolimus or other compoments of Certican®
- Lactose intolerance
- Pregnancy or lactation
- Women in reproductive age, except of women with the following criteria:
- Postmenopausal (12 month natural amenorrhea)
- Postoperativ (≥ 6 months after bilateral ovariectomy with / without hysterectomy)
- During therapy and at least 6 months after the last application of Everolimus: regular and correct high-effective contraception (Pearl-Index < 1; e. g. oral contraception, intrauterine device, implantate, contraceptive patch, combination of barrier methods (condom and cervical cap/diaphragm), abstinence
- Men, not using one of the following methods of contraception during therapy and at least 6 month after the last application of Everolimus:
- Sexual abstinence
- Vasectomy
- Condom
- Impairments or diseases reducing the ability of informed consent
- Participation of another study (e.g. for prophylactic immunsuppression in the stem cell transplantation procedure) within the last 60 day before recruitment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zentrum für Knochenmark- und Blutstammzelltransplantation,
Wiesbaden, Hesse, 65191
About this study
In this prospective study is to examine whether the use of everolimus in patients after allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is appropriate.
- Being tested
- Everolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Everolimus: Certican®
Start therapy: 2x 0.75 mg/day (morning and evening) to receive a serum trough level of 3 - 5 ng/ml. First evaluation of Everolimus serum level 3-7 days after start of therapy, second 7 days later, subsequently on study weeks 4, 6, 9, 12 and 16. Dose has to be adapted if trough level exceeds 5 ng/ml. As soon as Everolimus trough level exceeds 3 ng/ml after start of therapy, calineurine inhibitors (e.g. cyclosporine) will be reduced: halve of the dose for the 3 consecutive days, withdrawal on day 4.
Prednisone will be reduced accordingly (a 22 weeks scheme is recommended) Everolimus will be used for 98 days or 14 weeks, as described above Everolimus therapy might be extended (independently of the study) if the patient suffering from milde chronic GvHD (according to NIH criteria) or milde PTOLD and lung function score is not reduced more than 25% since begin of Everolimus therapy Everolimus will be reduced to 50% of the dosage for 2 weeks before withdraw (normally weeks 15 and 16
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | All patients will be given everolimus and the magnitude of the side effects will be measured Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus
Primary endpoint Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus
Reasons for withdrawal of Everolimus treatment:
- Unacceptabel toxicity
- Therapy failure:
- Recurrence of moderate or severe chronic GvHD (according to NIH criteria), clearly differentiated from acute forms of GvHD
- Reduction of LFS of more than 25% compared to the last value within 14 days before Everolimus treatment
- Therapy with immunosuppressive drugs in addition to Everolimus
Measured: 16 months
Secondary outcomes (1)
Adverse drug reactions on Everolimus
- Adverse drug reactions on Everolimus
- Frequency and grading of GvHD (according to NIH concerns) and POLT
- Lung function score (LFS)
- Overall survival
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study start1 Nov 2011
- Primary completion30 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Klinik fuer Diagnostik, ClinAssess GmbH
- Responsible party
- Sponsor
- Investigators
- Michael Schleuning, Prof. Dr. med., Principal investigator, Stiftung Deutsche Klinik für Diagnostik GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509560
- Sponsor's protocol ID
- Ev02 (Everolimus-GvHD)
- Other IDs
- 2010-023630-24
- Status last verified
- Feb 2017
- First submitted
- 3 Jan 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood
- ClinicalTrials.gov ID
- NCT01509560
- Acronym / sponsor ID
- Ev02 (Everolimus-GvHD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbHUniversity, hospital or other
- Collaborators
- Deutsche Klinik fuer Diagnostik, ClinAssess GmbH
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 13 Jan 2012 (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.
In this prospective study is to examine whether the use of everolimus in patients after allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Drug: EverolimusAll patients will be given everolimus and the magnitude of the side effects will be measured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients after allogeneic stem cell transplantation aged ≥ 18 years
- Prophylaxes of GvHD with calcineurin inhibitors (Ciclosporine A, Tacrolimus) and MTX or MMF (previous therapy of acute GvHD with additional prednisone is permitted)
- Increased risk of chronic GvHD, defined by
- Male with female donor
- HLA mismatch class I- or II towards GvHD
Key exclusion criteria (20 listed)
- Use (prophylactic or therapeutic) of mTor inhibitors after SCT
- Overlap of acute and chronic GvHD
- Total cholesterol ≥ 3-fold of upper limit (UL) or triglycerides ≥ 3-fold UL
- GOT, GPT, Bilirubin ≥ 3-fold UL (if not related to GvHD)
- Creatinine ≥ 3-fold UL
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 |
|---|---|---|
| EverolimusAlso: Everolimus: Certican®Start therapy: 2x 0.75 mg/day (morning and evening) to receive a serum trough level of 3 - 5 ng/ml. First evaluation of Everolimus serum level 3-7 days after start of therapy, second 7 days later, subsequently on study weeks 4, 6, 9, 12 and 16. Dose has to be adapted if trough level exceeds 5 ng/ml. As soon as Everolimus trough level exceeds 3 ng/ml after start of therapy, calineurine inhibitors (e.g. cyclosporine) will be reduced: halve of the dose for the 3 consecutive days, withdrawal on day 4. Prednisone will be reduced accordingly (a 22 weeks scheme is recommended) Everolimus will be used for 98 days or 14 weeks, as described above Everolimus therapy might be extended (independently of the study) if the patient suffering from milde chronic GvHD (according to NIH criteria) or milde PTOLD and lung function score is not reduced more than 25% since begin of Everolimus therapy Everolimus will be reduced to 50% of the dosage for 2 weeks before withdraw (normally weeks 15 and 16 | Drug | Everolimus |
Primary outcome
Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus
Time frame: 16 months
Primary endpoint Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus Reasons for withdrawal of Everolimus treatment: * Unacceptabel toxicity * Therapy failure: * Recurrence of moderate or severe chronic GvHD (according to NIH criteria), clearly differentiated from acute forms of GvHD * Reduction of LFS of more than 25% compared to the last value within 14 days before Everolimus treatment * Therapy with immunosuppressive drugs in addition to Everolimus
1 secondary outcome
Adverse drug reactions on Everolimus
Time frame: 16 months
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 Feb 2017.
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.
Michael Schleuning, Prof. Dr. med. principal investigator
Stiftung Deutsche Klinik für Diagnostik GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Everolimus in people with Condition After Allogenic Peripheral Stem Cell Transplantation (SCT), run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH 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 9 inclusion and 20 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 Feb 2017. 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 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?
Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus (time frame: 16 months). 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 Feb 2017; AzTrials last refreshed its copy on 30 Oct 2026.