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

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Status and phase: Completed; Phase 2

Conditions: Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01509560

2010-023630-24 (EudraCT Number)

Ev02 (Everolimus-GvHD)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Everolimus

Experimental group

Description:

All patients will be given everolimus and the magnitude of the side effects will be measured

Treatment:

Drug: Everolimus