Single-centre Study of Everolimus as GvHD Prophylaxis After Post-Transplantation Cyclophosphamide After Allogeneic SCT
NCT ID: NCT02812940
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2016-04-30
2020-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Everolimus as part of GvHD prophylaxis after allogeneic SCT
Everolimus from day +5 to day +100
Everolimus
GvHD prophylaxis
Interventions
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Everolimus
GvHD prophylaxis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
• Written informed consent
Exclusion Criteria
* 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%
* 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
18 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Christoph Scheid
Prof. Dr. Christoph Scheid
Principal Investigators
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Christof Scheid, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Locations
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University of Cologne
Cologne, , Germany
Countries
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Other Identifiers
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Uni-Koeln 1717
Identifier Type: -
Identifier Source: org_study_id
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