Prevention of chronic graft-versus-host disease and late pulmonary complications after allogeneic hematopoietic stem cell transplantation blood MedDRA version: 14.0 Level: PT Classification code 10053239 Term: Prophylaxis against graft versus host disease System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Certican
Product Name: Everolimus
Product Code: Everolimus
Pharmaceutical Form: Tablet
Trade Name: Certican
Product Name: Everolimus
Product Code: Everolimus
Pharmaceutical Form: Tablet
Sponsors
GMIHO mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • patients after allogeneic blood stem cell transplantation at the age = 18 years • GvHD prophylaxis with calcineurin inhibitors (cyclosporine A, tacrolimus) and MTX or MMF (Prior therapy of acute GvHD with additional prednisolone is allowed) • Increased risk of chronic GvHD, at least one of the following conditions is met: • Male with female donor • HLA class I or II mismatch in the GvHD direction • Continued active acute GvHD on day +50 after transplantation, despite treatment with high dose steroids and cyclosporine A • Functional one-second-forced vital capacity (FEV1) or diffusion capacity (DLCO) on day +50 after transplantation at least. 25% below the last measured value before transplantation (up to 50 days before transplantation) • New-onset of acute GvHD between day +50 and +100 after allogeneic blood stem cell transplantation • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • use (prophylactic or therapeutic) of mTOR inhibitors after SCT • Overlap of acute / chronic GvHD • Total cholesterol = 3 times the upper limit of normal (ULN) or triglycerides = 3 X ULN • GOT, GPT, bilirubin = 3 times ULN (unless attributable to GvHD) • creatinine = 3 times ULN • evidence of active hepatitis B or C • All of the circumstances in which wound healing may pose a risk, including: surgery in recent weeks, ulcers on the skin or mucous membrane • Known intolerance to everolimus, sirolimus, or other components of Certican ® • Lactose intolerance • Pregnancy or breastfeeding • Women of childbearing potential except women who meet the following criteria: • Post-menopausal (12 months natural amenorrhea) • After surgery (= 6 weeks after bilateral ovariectomy with or without hysterectomy) • during and at least 6 months after the last dose of everolimus regular and correct use of highly effective contraception (defined as Pearl Index <1) such as birth control pills, hormone IUD, hormonal implants, transdermal patch , a combination of two barrier methods (condom and diaphragm), sexual abstinence • Men who do not use one of the following options for contraception during at least 6 months after the last dose of everolimus : • Sexual abstinence • Condition after vasectomy • Condom • restrictions or conditions that affect the ability of a written Informed Consent • Participation in another interventional study (e.g., for prophylactic immunosuppression in the context of stem cell therapy) within the last 60 days prior to study enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients with early everolimus - Discontinuation of therapy, within 6 weeks beginning treatment with everolimus. The therapy is terminated under the following Conditions: - Unreasonable toxicities - treatment failure, defined as - new onset of chronic GVHD of moderate or strong expression to NIH criteria clearly represents no acute form of GVHD. -deterioration of the LFS to less than 75% of the Baseline value before the start of everolimus therapy - Regulation of an additional immunosuppressive Therapy - secondary endpoint side effects ;Main Objective: Frequency of treatment dropout in the first 6 Weeks ;Secondary Objective: - tolerability of everolimus -frequency and severity of GVHD (graft-versus-host Disease, acc. NIH consensus)and PTOLD (Transplant-associated obstructive Lung disease) - lung function - overall survival after Stammzelltransplantationl | — |
Countries
Germany
Outcome results
None listed