Prevention of the Graft-Versus-Host-Disease in Patients After Stem Cell Transplantation With Tacrolimus and Everolimus

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this pilot study is to provide preliminary data about the efficacy and the safety of the combination of tacrolimus with everolimus in the prophylaxis of the graft-versus-host-disease (GvHD) in patients after allogeneic stem cell transplantation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Male and female patients between 18 and 70 years of age

• Planned allogeneic stem cell transplantation either from a related or an unrelated donor

• Written informed consent

Exclusion Criteria:

• Previous stem cell transplantation

• Use of antibody Campath (anti CD-52) or ATG during the conditioning

• In vitro T-cell depleted graft

• Known hypersensitivity to everolimus or other constituents of the study medication

• Symptomatic infectious disease

• Hepatic disease (ASAT > 2 x ULN)

• Renal insufficiency (creatinine > 2 x ULN)

• HIV infection

• Life expectancy < 3 months

• Severe lung disease (FEV1 < 50% of the normal value)

• Severe psychiatric disorder

• Subjects unlikely to comply with the requirements of the protocol

• Known or current alcohol, medication or drug abuse

• Pregnancy or lactation

• Women of child-bearing potential without reliable contraception unless they meet the following criteria: postmenopausal (12 months of natural amenorrhea);postoperation status (6 weeks after surgical bilateral oophorectomy with or without hysterectomy);use of highly effective birth control method (defined as one which results in a low failure rate i.e. less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomized partner)

• Men that do not use one of the following methods for prevention of conception:sexual abstinence; condom; vasectomy

• Participation of the subject in another clinical trial within the last 4 weeks