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

Phase 2

Completed

• Conditions: Condition After Allogenic Peripheral Stem Cell Transplantation (SCT)
• Interventions: Drug: Everolimus

• Registration Number: NCT01509560
• Lead Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-01
• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolimus	All patients will be given everolimus and the magnitude of the side effects will be measured

Primary Outcome Measures

Name	Time	Method
Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus	16 months	Primary endpoint Frequency of early withdrawal of treatment within the first 6 weeks on Everolimus; Reasons for withdrawal of Everolimus treatment: * Unacceptabel toxicity; * Therapy failure: * Recurrence of moderate or severe chronic GvHD (according to NIH criteria), clearly differentiated from acute forms of GvHD; * Reduction of LFS of more than 25% compared to the last value within 14 days before Everolimus treatment; * Therapy with immunosuppressive drugs in addition to Everolimus

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions on Everolimus	16 months	* Adverse drug reactions on Everolimus; * Frequency and grading of GvHD (according to NIH concerns) and POLT; * Lung function score (LFS); * Overall survival

Trial Locations

Locations (1)

Zentrum für Knochenmark- und Blutstammzelltransplantation,; 🇩🇪 Wiesbaden, Hessen, Germany