Status:
COMPLETED
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
Lead Sponsor:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Collaborating Sponsors:
Deutsche Klinik fuer Diagnostik
ClinAssess GmbH
Conditions:
Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01509560
Start Date
November 1 2011
End Date
April 30 2016
Last Update
February 23 2017
Active Locations (1)
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1
Zentrum für Knochenmark- und Blutstammzelltransplantation,
Wiesbaden, Hesse, Germany, 65191