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