Graft-versus-Host DiseasePhase 2OCTET-EverNCT02812940

Single-centre Study of Everolimus as GvHD Prophylaxis After Post-Transplantation Cyclophosphamide After Allogeneic SCT

A Phase 2 study testing Everolimus in people with Graft-versus-Host Disease, run by University of Cologne at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A phase II clinical study to assess the efficacy of short-term everolimus as prophylaxis for Graft-versus-Host disease (GvHD) in addition to post-transplantation cyclophosphamide after allogeneic hematopoietic stem cell transplantation in patients with haematological malignancies 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?: Everolimus
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteGermany
Study dates: Apr 2016to Dec 2020
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 with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide
Principal inclusion criteria:
Written informed consent

Who cannot join

Known intolerance to everolimus
Presence or history of Microangiopathy
Presence of uncontrolled infections
Severe organ dysfunction defined as:
Cardiac left ventricular ejection fraction (LVEF) of less than 35%
Diffusing lung capacity (DLCO) of less than 40%

Show all 12Show fewer

Total lung capacity (TLC) of less than 40%
Forced expiratory volume (FEV1) of less than 40%
Total bilirubin >3mg/dl
Creatinine-clearance of less than 40 ml/min
Pregnancy or breast feeding
Participation in other experimental drug trials

Trial locations and contacts

1 site in 1 country.

Germany1 site

University of Cologne
Cologne, 50924

Other trials in Germany

About this study

Official title: A Single-centre Study of Certican (Everolimus) as Prophylaxis for Graft-versus-Host Disease Following Post-Transplantation Cyclophosphamide After Allogeneic Stem Cell Transplantation

Read the detailed description

Title of the clinical study: A single-centre study of Certican (everolimus) as Prophylaxis for Graft-versus-Host Disease following Post-Transplantation Cyclophosphamide after Allogeneic Stem Cell Transplantation (OCTET-EVER)

Indication: Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide

Phase: Phase II clinical study

Type of study, study design, methodology: Single centre single arm clinical trial, A'Hern's single stage phase II procedure

Number of subjects: 20 (17 total evaluable)

Primary study objective To assess the efficacy of short-term everolimus as GvHD prophylaxis in addition to post-transplantation cyclophosphamide after allogeneic hematopoietic stem cell transplantation in patients with haematological malignancies and to describe the influence of the modified immunosuppression concept on the incidence and severity of acute GvHD, relapse rates, minimal residual disease, immune reconstitution and chimerism.

Medical condition or disease to be investigated:

Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide

Name of investigational medicinal product (IMP): Everolimus (Certican®) Investigational medicinal product - dosage and method of administration: 1,5mg per os twice a day (target blood level 5 to 10ng/ml) from day +5 to day +100 after allogeneic stem cell transplantation

Duration of treatment: The treatment will be given from day +5 to day +100 after allogeneic stem cell transplantation. The observation time will last from day +5 to day +130. Incidence of chronic GvHD, overall survival and relapse incidence will be recorded on d+365 and d+720 after transplant.

Conditions: Graft-versus-Host Disease
Being tested: Everolimus
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
Also called Certican
GvHD prophylaxis

Study groups in NCT02812940
Study group	Role	What they receive
Everolimus as part of GvHD prophylaxis after allogeneic SCT	Experimental	Everolimus from day +5 to day +100 Receives: Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation
GvHD
Measured: day 100 after transplantation

Secondary outcomes (9)

Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation
GvHD
Measured: day 100 after transplantation
Incidence of severe chronic GvHD
cGvHD
Measured: 720 days after transplantation
Incidence of overall chronic GvHD
cGvHD
Measured: 720 days after transplantation
Relapse incidence
Relapse
Measured: 720 days after transplantation
Non-relapse mortality
NRM
Measured: 720 days after transplantation
Overall survival
OS
Measured: 720 days after transplantation
Immune reconstitution
Number of CD3, CD4, CD8, CD20 and CD56 positive cells in peripheral blood
Measured: day 100 after transplantation
Engraftment
absolute neutrophil count > 500/ul and platelet count > 50.000/ul
Measured: day 100 after transplantation
Chimerism
% donor cells in peripheral blood or bone marrow
Measured: day 100 after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Dec 2020

First posted24 Jun 2016 (estimated)
Study startApr 2016
Primary completionJul 2019
Study completionDec 2020

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.
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: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02812940
Sponsor's protocol ID: Uni-Koeln 1717
Acronym: OCTET-Ever
Status last verified: Mar 2021
First submitted: 19 Jun 2016
Last updated: 17 Mar 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
RecruitingPhase 1/2
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
HIV, Hematologic Malignancies

All Graft-versus-Host Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-centre Study of Certican (Everolimus) as Prophylaxis for Graft-versus-Host Disease Following Post-Transplantation Cyclophosphamide After Allogeneic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT02812940
Acronym / sponsor ID: OCTET-Ever / Uni-Koeln 1717
Conditions: Graft-versus-Host Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of CologneUniversity, hospital or other
Study start: Apr 2016
Primary completion: Jul 2019 (actual)
Study completion: Dec 2020 (actual)
First posted: 24 Jun 2016 (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.

Detailed description

Phase: Phase II clinical study

Type of study, study design, methodology: Single centre single arm clinical trial, A'Hern's single stage phase II procedure

Number of subjects: 20 (17 total evaluable)

Medical condition or disease to be investigated:

Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Everolimus as part of GvHD prophylaxis after allogeneic SCT	Experimental	Drug: EverolimusEverolimus from day +5 to 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)

Patients with haematological malignancies after allogeneic haematopoietic stem cell transplantation with a matched related or unrelated donor following reduced intensity conditioning and post-transplantation cyclophosphamide
Written informed consent

Key exclusion criteria (12 listed)

Known intolerance to everolimus
Presence or history of Microangiopathy
Presence of uncontrolled infections
Severe organ dysfunction defined as:
Cardiac left ventricular ejection fraction (LVEF) of less than 35%

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: CerticanGvHD prophylaxis	Drug	Everolimus as part of GvHD prophylaxis after allogeneic SCT

Primary outcome

Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation
Time frame: day 100 after transplantation
GvHD

9 secondary outcomes

Incidence of acute GvHD II-IV° until day +100 after allogenic stem cell transplantation
Time frame: day 100 after transplantation
Incidence of severe chronic GvHD
Time frame: 720 days after transplantation
Incidence of overall chronic GvHD
Time frame: 720 days after transplantation
Relapse incidence
Time frame: 720 days after transplantation
Non-relapse mortality
Time frame: 720 days after transplantation
Overall survival
Time frame: 720 days after transplantation
Immune reconstitution
Time frame: day 100 after transplantation
Engraftment
Time frame: day 100 after transplantation
Chimerism
Time frame: day 100 after transplantation

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 17 Mar 2021.
Individual participant dataSharing planned: No

Related trials for Graft-versus-Host Disease

RecruitingPhase 1
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Active, not recruiting
Multimodal Manual Therapy vs. Maitland Mobilization for Chronic Non-Specific Neck Pain
Chronic Neck Pain
RecruitingPhase 1/2
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
HIV, Hematologic Malignancies

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.

Christof Scheid, Prof. Dr. principal investigator

University of Cologne

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 Graft-versus-Host Disease, run by University of Cologne 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 3 inclusion and 12 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 17 Mar 2021. 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?

Incidence of acute GvHD III-IV° until day +100 after allogenic stem cell transplantation (time frame: day 100 after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02812940.

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 17 Mar 2021.