Overview

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

Status:
Completed
Trial end date:
2016-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH
Collaborators:
ClinAssess GmbH
Deutsche Klinik fuer Diagnostik
Treatments:
Everolimus
Sirolimus
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