EUCTR2010-023630-24-DEActive, not recruitingPhase 1
Phase II open-label pilot study evaluating the safety and efficacy of Certican ® (everolimus) in the prevention of chronic graft-versus-host disease and late pulmonary complications after allogeneic hematopoietic stem cell transplantation blood - GMIHO-004/2006
GMIHO mbH0 sites25 target enrollmentStarted: January 3, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •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
Investigators
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