Clinical trial NCT01509560: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)
Lead sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Sponsor class: OTHER
Collaborators: name: Deutsche Klinik fuer Diagnostik
name: ClinAssess GmbH
First posted: 2012-01-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus
timeFrame: 16 months
Secondary outcomes:
measure: Adverse drug reactions on Everolimus
timeFrame: 16 months
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Zentrum für Knochenmark- und Blutstammzelltransplantation,
state: Hessen
Study officials:
affiliation: Stiftung Deutsche Klinik für Diagnostik GmbH
name: Michael Schleuning, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: